Calcium sulphate dihydrate – A diluent excipient for pharmaceutical

1. General introduction of Calcium Sulphate Dihydrate

Calcium sulphate dihydrate (CaSO₄·2H₂O)is a high-purity inorganic mineral salt derived from refined gypsum. It functions as a versatile excipient and performance-enhancing ingredient in both pharmaceutical and cosmetic formulations. In pharmaceuticals, it acts as a matrix-forming excipient, enabling controlled drug release while maintaining the mechanical integrity of solid dosage forms. In cosmetics, it serves as a filler, opacifying agent, and rheology modifier, improving sensory properties and product stability. Thanks to its multi-industry applicability, calcium sulphate dihydrate has become a strategic ingredient for developing premium and differentiated formulations.

2. Active Composition of Calcium Sulphate Dihydrate

Primary Component:Calcium sulphate dihydrate (CaSO₄·2H₂O)

Physicochemical Properties:

Structure: Ionic crystal lattice composed of Ca²⁺ and SO₄²⁻ with two molecules of crystallization water
Appearance: White to off-white crystalline powder
Solubility: Slightly soluble in water → forms a semi-permeable matrix system
Thermal Behavior: Loses crystallization water at ~100–150°C → converts to hemihydrate form
Stability: Chemically inert with minimal interaction with active ingredients

Mechanism in Formulations:

Forms a porous, low-solubility matrix controlling water penetration
Modulates active ingredient diffusion rates
Enhances mechanical strength of tablets

3. Key Advantages of Calcium Sulphate Dihydrate

Controlled-release matrix formation: Eliminates the need for complex polymer systems
Low hygroscopicity: High stability in humid environments
Excellent compressibility: Suitable for direct compression, reducing auxiliary excipients
Thermal adaptability: Supports advanced processing techniques
Multifunctionality: Acts as filler, stabilizer, and release controller
Improves cosmetic sensorials: Enhances smoothness, coverage, and opacity
High batch consistency: Ensures reproducibility across production batches

4. Applications of Calcium Sulphate Dihydrate

Pharmaceutical Applications (High-Value)

Controlled-release tablets: Matrix excipient for sustained/modified release (SR/MR), reducing dosing frequency and improving patient compliance
High-dose tablets: Maintains mechanical strength and minimizes tableting defects
Powder-filled capsules: Improves flowability and content uniformity

Cosmetic Applications (Premium Segment)

Face powders & pressed powders: Filler, anti-caking agent, improves smoothness, delivers a refined skin finish
Creams & cleansers: Opacifier and emulsion stabilizer, enhances perceived product quality
Toothpaste: Mild abrasive for effective cleaning
Modeling masks: Used in professional spa/dermatological treatments

Extended Applications (Biomedical)

Bone void fillers
Antibiotic delivery system

5. Commercial Products using Calcium Sulphate Dihydrate

6. Product contact Information

For more information on Calcium carbonate supply, please contact us:

Consultation Hotline: +84 (0) 834 560 500
Email:: director@biorichgroup.com
Website: www.biorichgroup.com
Sample / COA Request: Please contact us via email to receive samples and the latest Certificate of Analysis (COA).

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{"id":739778,"name":"Calcium sulphate dihydrate – A diluent excipient for multiple pharmaceutical formulations","desc":"Calcium sulphate dihydrate <\/strong>is an inorganic salt of calcium and sulfate that naturally occurs as the mineral gypsum<\/strong>. In the pharmaceutical industry, it is primarily used as a diluent excipient in tablet and capsule formulations due to its excellent compressibility, high chemical stability, inert nature, and negligible hygroscopicity.<\/span><\/p>","content":"<figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/Avatar sản phẩm\/Calcium sulphate dihydrate avatar - Biorich Group.jpg\" alt=\"\"><\/figure><h2>1. General introduction of Calcium Sulphate Dihydrate<\/strong><\/span><\/h2>Calcium sulphate dihydrate (CaSO₄·2H₂O)<\/strong><\/span> <\/strong><\/span>is a high-purity inorganic mineral salt derived from refined gypsum. It functions as a versatile excipient and performance-enhancing ingredient in both pharmaceutical and cosmetic formulations. In pharmaceuticals, it acts as a matrix-forming excipient, enabling controlled drug release while maintaining the mechanical integrity of solid dosage forms. In cosmetics, it serves as a filler, opacifying agent, and rheology modifier, improving sensory properties and product stability. Thanks to its multi-industry applicability, calcium sulphate dihydrate has become a strategic ingredient for developing premium and differentiated formulations.<\/span><\/p><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/Sản phẩm\/Calcium sulphate dihydrate giới thiệu chung - Biorich Group.jpg\" alt=\"\"><\/figure><h2>2. Active Composition of Calcium Sulphate Dihydrate<\/strong><\/span><\/h2>Primary Component:<\/strong><\/span> <\/strong>Calcium sulphate dihydrate (CaSO₄·2H₂O)<\/span><\/p>Physicochemical Properties:<\/strong><\/span><\/p><ul><li>Structure:<\/strong><\/span> Ionic crystal lattice composed of Ca²⁺ and SO₄²⁻ with two molecules of crystallization water<\/span><\/li><li>Appearance:<\/strong><\/span> White to off-white crystalline powder<\/span><\/li><li>Solubility:<\/strong><\/span> Slightly soluble in water → forms a semi-permeable matrix system<\/span><\/li><li>Thermal Behavior:<\/strong><\/span> Loses crystallization water at ~100–150°C → converts to hemihydrate form<\/span><\/li><li>Stability:<\/strong><\/span> Chemically inert with minimal interaction with active ingredients<\/span><\/li><\/ul>Mechanism in Formulations:<\/strong><\/span><\/p><ul><li>Forms a porous, low-solubility matrix controlling water penetration<\/span><\/li><li>Modulates active ingredient diffusion rates<\/span><\/li><li>Enhances mechanical strength of tablets<\/span><\/li><\/ul><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/Sản phẩm\/Calcium sulphate dihydrate thành phần hoạt chất - Biorich Group.jpg\" alt=\"\"><\/figure><h2>3. Key Advantages of Calcium Sulphate Dihydrate<\/strong><\/span><\/h2><ul><li>Controlled-release matrix formation:<\/strong><\/span> Eliminates the need for complex polymer systems<\/span><\/li><li>Low hygroscopicity:<\/strong><\/span> High stability in humid environments<\/span><\/li><li>Excellent compressibility:<\/strong><\/span> Suitable for direct compression, reducing auxiliary excipients<\/span><\/li><li>Thermal adaptability:<\/strong><\/span> Supports advanced processing techniques<\/span><\/li><li>Multifunctionality:<\/strong><\/span> Acts as filler, stabilizer, and release controller<\/span><\/li><li>Improves cosmetic sensorials:<\/strong><\/span> Enhances smoothness, coverage, and opacity<\/span><\/li><li>High batch consistency:<\/strong><\/span> Ensures reproducibility across production batches<\/span><\/li><\/ul><h2>4. Applications of Calcium Sulphate Dihydrate<\/strong><\/span><\/h2>Pharmaceutical Applications (High-Value)<\/strong><\/span><\/p><ul><li>Controlled-release tablets:<\/strong><\/span> Matrix excipient for sustained\/modified release (SR\/MR), reducing dosing frequency and improving patient compliance<\/span><\/li><li>High-dose tablets:<\/strong><\/span> Maintains mechanical strength and minimizes tableting defects<\/span><\/li><li>Powder-filled capsules:<\/strong><\/span> Improves flowability and content uniformity<\/span><\/li><\/ul>Cosmetic Applications (Premium Segment)<\/strong><\/span><\/p><ul><li>Face powders &amp; pressed powders:<\/strong><\/span> Filler, anti-caking agent, improves smoothness, delivers a refined skin finish<\/span><\/li><li>Creams &amp; cleansers:<\/strong><\/span> Opacifier and emulsion stabilizer, enhances perceived product quality<\/span><\/li><li>Toothpaste:<\/strong><\/span> Mild abrasive for effective cleaning<\/span><\/li><li>Modeling masks:<\/strong><\/span> Used in professional spa\/dermatological treatments<\/span><\/li><\/ul>Extended Applications (Biomedical)<\/strong><\/span><\/p><ul><li>Bone void fillers<\/strong><\/span><\/li><li>Antibiotic delivery system<\/strong><\/span><\/li><\/ul><h2>5. Commercial Products using Calcium Sulphate Dihydrate<\/strong><\/span><\/h2><img class=\"image_resized\" style=\"width:20.29%;\" src=\"\/datafiles\/88336\/upload\/images\/2026-04\/image(32).png\"><img class=\"image_resized\" style=\"width:32.96%;\" src=\"\/datafiles\/88336\/upload\/images\/2026-04\/image(33).png\"><\/strong><\/span><\/p><h2>6. Product contact Information<\/strong><\/span><\/h2>For more information on<\/span> Calcium carbonate<\/strong><\/span> supply, please contact us:<\/span><\/p><ul><li>Consultation Hotline:<\/strong> +84 (0) 834 560 500<\/span><\/li><li>Email:<\/strong> : <\/strong><\/span><a href=\"mailto:director@biorichgroup.com\">director@biorichgroup.com<\/span><\/a><\/li><li>Website: <\/strong>www.biorichgroup.com<\/span><\/li><li>Sample \/ COA Request: <\/strong>Please contact us via email to receive samples and the latest Certificate of Analysis (COA).<\/span><\/li><\/ul>&nbsp;<\/p>","image_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/images\/2026-04\/Calcium%20sulphate%20dihydrate%20-%20Biorich%20Group%282%29.jpg","image_thumb_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/thumb_images\/2026-04\/Calcium%20sulphate%20dihydrate%20-%20Biorich%20Group%282%29.jpg","tags":["calcium sulphate dihydrate","pharma excipient","cosmetic ingredient","controlled release","formulation stability","matrix excipient"],"count_view":204,"seo_name":"calcium-sulphate-dihydrate-a-diluent-excipient-for-multiple-pharmaceutical-formulations","date_update":1775463780,"date_created_format":1775467620,"meta_title":"Calcium sulphate dihydrate – A diluent excipient for pharmaceutical","meta_desc":"Calcium sulphate dihydrate is an inorganic salt of calcium and sulfate that naturally occurs as the mineral gypsum. 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High-quality pharmaceutical-grade raw material, providing outstanding superdisintegrant effects, optimizing solubility for tablet and capsule formulations. Contact Biorich now!<\/p>","content":"<figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Starch Glycolate – Tá dược siêu rã chất lượng cao từ Ấn Độ(2).jpg\"><\/figure><h2>1. General Introduction to Sodium Starch Glycolate<\/strong><\/h2>Sodium Starch Glycolate is a modified starch, notable for its rapid water absorption and strong swelling capabilities. This active ingredient is widely applied as a superdisintegrant excipient in pharmaceutical formulations, helping tablets and capsules disintegrate quickly upon contact with gastric fluid, thereby accelerating the release rate and bioavailability of the active ingredient.<\/p>The raw material is manufactured by Gangwal Healthcare Pvt Ltd (India), a reputable manufacturer of pharmaceutical chemicals and excipients. With an advanced manufacturing process, Gangwal's Sodium Starch Glycolate achieves superior quality, strictly controlling microbial and impurity standards, ensuring absolute consistency between production batches, and fully meeting the most stringent global Pharmacopoeia standards.<\/p><h2>2. Material Information of Sodium Starch Glycolate<\/strong><\/h2><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Starch Glycolate (2)(1).png\"><\/figure><ul><li>Material Name<\/strong><\/span>:<\/strong> Sodium Starch Glycolate<\/li><li>Manufacturer<\/strong><\/span>:<\/strong> Gangwal Healthcare Pvt Ltd<\/li><li>Origin<\/strong><\/span>:<\/strong> India<\/li><li>Material Group<\/strong><\/span>:<\/strong> Pharmaceutical Excipients \/ Superdisintegrants.<\/li><li>Function<\/strong><\/span>:<\/strong> Helps tablets and capsules disintegrate quickly, enhancing solubility and absorption of pharmaceutical substances.<\/li><li>Chemical Composition<\/strong><\/span>:<\/strong> Sodium salt of carboxymethyl ether of starch.<\/li><li>Material Form<\/strong><\/span>:<\/strong> White or off-white, free-flowing powder, odorless or with a slight odor.<\/li><li>Solubility<\/strong><\/span>:<\/strong> Practically insoluble in water but swells immensely in water; insoluble in most organic solvents.<\/li><li>Quality Standards<\/strong><\/span>:<\/strong> Meets US Pharmacopeia (USP), European Pharmacopoeia (EP), or British Pharmacopoeia (BP) standards.<\/li><\/ul><h3>The material is specially and strictly controlled for:<\/strong><\/h3><ul><li>Swelling capacity<\/strong><\/span>:<\/strong> Ensures optimal swelling in aqueous environments (many times its original volume) to break down the tablet structure quickly.<\/li><li>Impurity and microbial limits<\/strong><\/span>:<\/strong> Strictly controls heavy metal content and meets stringent microbial standards for oral preparations.<\/li><\/ul><h3>3. Advantages of Sodium Starch Glycolate from Gangwal<\/strong><\/h3><ul><li>Impressive superdisintegrant effect<\/strong><\/span>:<\/strong> Strong water absorption and swelling capabilities help tablets disintegrate rapidly even when used at low concentrations (typically 2% - 8%).<\/li><li>High compatibility<\/strong><\/span>:<\/strong> Suitable for various tableting methods (direct compression, wet granulation, dry granulation) and highly compatible with most pharmaceutical active ingredients.<\/li><li>Outstanding stability<\/strong><\/span>:<\/strong> Disintegration capability is not diminished under high compression forces during tableting and remains effective throughout the drug's shelf life.<\/li><li>Reasonable cost - Stable supply<\/strong><\/span>:<\/strong> Manufactured in India by Gangwal Healthcare, the product has an optimally competitive price, providing an effective solution for factories to optimize production costs.<\/li><\/ul><h2>4. Applications of Sodium Starch Glycolate<\/strong><\/h2><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Starch Glycolate (3)(1).png\"><\/figure><h3>In Pharmaceuticals (Core Application)<\/strong><\/h3><ul><li>Tablets and capsules<\/strong><\/span>:<\/strong> Acts as a superdisintegrant (added both intra-granularly and extra-granularly) for solid oral dosage forms, facilitating the rapid release of medicinal substances.<\/li><\/ul><h3>In Health Supplements<\/strong><\/h3><ul><li>Nutritional supplement tablets<\/strong><\/span>:<\/strong> Applied in vitamin, mineral, or herbal extract tablets to ensure the product disintegrates easily in the stomach, maximizing absorption.<\/li><\/ul><h2>5. Commercial Products Using Sodium Starch Glycolate<\/strong><\/h2><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Starch Glycolate (4)(1).png\"><\/figure><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Starch Glycolate (1)(1).png\"><\/figure><h2>6. Product Contact Information<\/strong><\/h2>For more information on the supply chain, technical specifications of Sodium Starch Glycolate, or to place an order, please contact us:<\/p><ul><li>Consulting Hotline:<\/strong> +84 (0) 834 560 500<\/li><li>Email:<\/strong> <a href=\"mailto:director@biorichgroup.com\">director@biorichgroup.com<\/a>&nbsp;<\/li><li>Website:<\/strong> <a href=\"https:\/\/www.google.com\/search?q=https%3A%2F%2Fwww.biorichgroup.com\">www.biorichgroup.com<\/a><\/li><li>Sample\/COA Request:<\/strong> Please contact us via email to request a test sample and the latest Certificate of Analysis (COA) of the raw material from the manufacturer Gangwal Healthcare Pvt Ltd.<\/li><\/ul>","image_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/images\/Avatar%20s%E1%BA%A3n%20ph%E1%BA%A9m\/Sodium%20Starch%20Glycolate%20%E2%80%93%20T%C3%A1%20d%C6%B0%E1%BB%A3c%20si%C3%AAu%20r%C3%A3%20ch%E1%BA%A5t%20l%C6%B0%E1%BB%A3ng%20cao%20t%E1%BB%AB%20%E1%BA%A4n%20%C4%90%E1%BB%99.jpg","image_thumb_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/thumb_images\/Avatar%20s%E1%BA%A3n%20ph%E1%BA%A9m\/Sodium%20Starch%20Glycolate%20%E2%80%93%20T%C3%A1%20d%C6%B0%E1%BB%A3c%20si%C3%AAu%20r%C3%A3%20ch%E1%BA%A5t%20l%C6%B0%E1%BB%A3ng%20cao%20t%E1%BB%AB%20%E1%BA%A4n%20%C4%90%E1%BB%99.jpg","tags":["Sodium Starch Glycolate","superdisintegrant excipient","Gangwal Healthcare","buy Sodium Starch Glycolate","Biorich pharmaceutical excipients"],"count_view":2,"seo_name":"sodium-starch-glycolate-premium-superdisintegrant-excipient-from-india","date_update":1783673340,"date_created_format":1783673595,"meta_title":"Sodium Starch Glycolate","meta_desc":"Sodium Starch Glycolate from Gangwal Healthcare Pvt Ltd (India). High-quality pharmaceutical-grade raw material, providing outstanding superdisintegrant effects, optimizing solubility for tablet and capsule formulations. Contact Biorich now!","meta_keyword":"Sodium Starch Glycolate,superdisintegrant excipient,Gangwal Healthcare,buy Sodium Starch Glycolate,Biorich pharmaceutical excipients","qr_code":"https:\/\/www.biorichgroup.com\/sodium-starch-glycolate-premium-superdisintegrant-excipient-from-india"},{"id":749994,"name":"Sodium Metabisulphite – Premium antioxidant and preservative excipient from India","desc":"Sodium Metabisulphite from Sujata Nutri-Pharma Pvt. Ltd. (India). High-quality pharmaceutical-grade raw material providing outstanding antioxidant and preservative effects for pharmaceutical and food formulations. Contact Biorich now!<\/p>","content":"<figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Metabisulphite – Tá dược chống oxy hóa và bảo quản cao cấp từ Ấn Độ(1).jpg\"><\/figure><h2>1. General Introduction to Sodium Metabisulphite<\/strong><\/h2>Sodium Metabisulphite (Sodium Metabisulfite) is an inorganic compound with strong antioxidant and antimicrobial properties. This active ingredient is widely used as an antioxidant excipient and preservative in pharmaceutical, cosmetic, and food industry formulations to prevent the degradation of main active ingredients.<\/p>The raw material is manufactured by Sujata Nutri-Pharma Pvt. Ltd. (India), a reputable chemical and excipient manufacturer. With an advanced synthesis and purification process, Sujata's Sodium Metabisulphite achieves optimal purity, strictly controls impurity indices, ensures absolute consistency between production batches, and fully meets the most stringent global pharmacopoeia standards.<\/p><h2>2. Material Information of Sodium Metabisulphite<\/strong><\/h2><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Metabisulphite (1)(1).png\"><\/figure><ul><li>Material Name<\/strong><\/span>:<\/strong> Sodium Metabisulphite (Sodium Metabisulfite)<\/li><li>Manufacturer<\/strong><\/span>:<\/strong> Sujata Nutri-Pharma Pvt. Ltd.<\/li><li>Origin<\/strong><\/span>:<\/strong> India<\/li><li>Material Group<\/strong><\/span>:<\/strong> Pharmaceutical Excipients \/ Antioxidants, preservatives.<\/li><li>Function<\/strong><\/span>:<\/strong> Antioxidant, prevents mold and bacteria, maintains the stability of pharmaceutical formulations.<\/li><li>Chemical Composition<\/strong><\/span>:<\/strong> Na2S2O5.<\/li><li>Material Form<\/strong><\/span>:<\/strong> White or slightly yellowish crystalline powder with a characteristic sulfur dioxide (SO2) odor.<\/li><li>Solubility<\/strong><\/span>:<\/strong> Very soluble in water and glycerin, slightly soluble in alcohol (ethanol).<\/li><li>Quality Standards<\/strong><\/span>:<\/strong> Meets US Pharmacopeia (USP), European Pharmacopoeia (EP), or British Pharmacopoeia (BP) standards.<\/li><\/ul><h3>The material is specially and strictly controlled for:<\/strong><\/h3><ul><li>Impurity limits<\/strong><\/span>:<\/strong> Strictly controls heavy metal content (such as arsenic, lead) and other inorganic impurities at extremely low levels below the thresholds prescribed by international pharmacopoeias.<\/li><li>SO2 content<\/strong><\/span>:<\/strong> Ensures the released sulfur dioxide content meets standards to maintain maximum antioxidant efficacy.<\/li><\/ul><h2>3. Advantages of Sodium Metabisulphite from Sujata<\/strong><\/h2><ul><li>High purity and safety:<\/strong> The purification process removes metal impurities, ensuring safety when used in oral and injectable preparations.<\/li><li>Strong antioxidant mechanism:<\/strong> Acts as a reducing agent, preferentially reacting with oxygen to protect easily oxidized pharmaceutical active ingredients (such as adrenaline, vitamin C).<\/li><li>Superior formulation properties:<\/strong> Excellent solubility in water, easily incorporated into solution and syrup formulations without altering the physical properties of the product.<\/li><li>Reasonable cost - Stable supply:<\/strong> Manufactured in India by Sujata Nutri-Pharma, the product has an optimally competitive price, providing an effective solution for factories to optimize production costs.<\/li><\/ul><h3>4. Applications of Sodium Metabisulphite<\/strong><\/h3><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Metabisulphite (2)(1).png\"><\/figure><h3>In Pharmaceuticals (Core Application)<\/strong><\/h3><ul><li>Injections and solutions<\/strong><\/span>:<\/strong> Used as an essential antioxidant excipient in injections, eye drops, and ear drops to protect sensitive pharmaceutical substances.<\/li><li>Liquid oral medications<\/strong><\/span>:<\/strong> Used as a preservative and antioxidant in syrups and oral suspensions.<\/li><li>Semi-solid dosage forms<\/strong><\/span>:<\/strong> Applied in creams and topical ointments to prevent the degradation of active ingredients.<\/li><\/ul><h3>In Health Supplements and Cosmetics<\/strong><\/h3><ul><li>Food preservation<\/strong><\/span>:<\/strong> Prevents oxidation that causes discoloration and inhibits the growth of microorganisms.<\/li><li>Personal care products<\/strong><\/span>:<\/strong> Acts to stabilize ingredients in water-based cosmetic formulations.<\/li><\/ul><h2>5. Commercial Products Using Sodium Metabisulphite<\/strong><\/h2><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Metabisulphite (3)(1).png\"><\/figure><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Metabisulphite (4)(1).png\"><\/figure><h2>6. Product Contact Information<\/strong><\/h2>For more information on the supply chain, technical specifications of Sodium Metabisulphite, or to place an order, please contact us:<\/p><ul><li>Consulting Hotline:<\/strong> +84 (0) 834 560 500<\/li><li>Email:<\/strong> director@biorichgroup.com<\/li><li>Website:<\/strong> <a href=\"https:\/\/www.google.com\/search?q=https%3A%2F%2Fwww.biorichgroup.com\">www.biorichgroup.com<\/a><\/li><li>Sample\/COA Request:<\/strong> Please contact us via email to request a test sample and the latest Certificate of Analysis (COA) of the raw material from the manufacturer Sujata Nutri-Pharma Pvt. Ltd.<\/li><\/ul>","image_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/images\/Avatar%20s%E1%BA%A3n%20ph%E1%BA%A9m\/Sodium%20Metabisulphite%20%E2%80%93%20T%C3%A1%20d%C6%B0%E1%BB%A3c%20ch%E1%BB%91ng%20oxy%20h%C3%B3a%20v%C3%A0%20b%E1%BA%A3o%20qu%E1%BA%A3n%20cao%20c%E1%BA%A5p%20t%E1%BB%AB%20%E1%BA%A4n%20%C4%90%E1%BB%99%281%29.jpg","image_thumb_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/thumb_images\/Avatar%20s%E1%BA%A3n%20ph%E1%BA%A9m\/Sodium%20Metabisulphite%20%E2%80%93%20T%C3%A1%20d%C6%B0%E1%BB%A3c%20ch%E1%BB%91ng%20oxy%20h%C3%B3a%20v%C3%A0%20b%E1%BA%A3o%20qu%E1%BA%A3n%20cao%20c%E1%BA%A5p%20t%E1%BB%AB%20%E1%BA%A4n%20%C4%90%E1%BB%99%281%29.jpg","tags":["Sodium Metabisulphite","Sodium Metabisulfite","tá dược chống oxy hóa","Sujata NutriPharma","mua Sodium Metabisulphite Biorich"],"count_view":9,"seo_name":"sodium-metabisulphite-ta-duoc-chong-oxy-hoa-va-bao-quan-cao-cap-tu-an-do","date_update":1783656600,"date_created_format":1783656696,"meta_title":"Sodium Metabisulphite","meta_desc":"Sodium Metabisulphite từ Sujata Nutri-Pharma Pvt. Ltd. (India). Nguyên liệu dược dụng chất lượng cao, mang lại tác dụng chống oxy hóa và bảo quản vượt trội cho các công thức dược phẩm và thực phẩm. Liên hệ Biorich ngay!","meta_keyword":"Sodium Metabisulphite,Sodium Metabisulfite,tá dược chống oxy hóa,Sujata NutriPharma,mua Sodium Metabisulphite Biorich","qr_code":"https:\/\/www.biorichgroup.com\/sodium-metabisulphite-ta-duoc-chong-oxy-hoa-va-bao-quan-cao-cap-tu-an-do"},{"id":749962,"name":"What Is Nitrosamine? Risks of Nitrosamine Impurities in Pharmaceutical Raw Materials","desc":"Learn what nitrosamines are, how they form in APIs and excipients, the associated risks, and current regulatory limits for pharmaceutical raw materials.&nbsp;<\/span><\/p>","content":"<figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/Tin kỹ thuật\/Nitrosamine banner.jpg\" alt=\"\"><\/figure><h2>1. What are Nitrosamines?<\/strong><\/span><\/h2>Nitrosamines are a class of compounds containing the&nbsp;<\/span>N-nitroso functional group (-N–N=O)<\/strong>.<\/span> They are generally formed through the reaction of amines with nitrosating agents, particularly nitrite under acidic conditions.<\/span><\/p>Nitrosamines of pharmaceutical concern include:<\/span><\/p><ul><li>N-Nitrosodimethylamine (NDMA)<\/strong><\/span><\/li><li>N-Nitrosodiethylamine (NDEA)<\/strong><\/span><\/li><li>N-Nitrosoethylisopropylamine (NEIPA)<\/strong><\/span><\/li><li>N-Nitrosodiisopropylamine (NDIPA)<\/strong><\/span><\/li><li>N-Nitrosodibutylamine (NDBA)<\/strong><\/span><\/li><\/ul>Many nitrosamines are classified as&nbsp;<\/span>mutagenic impurities<\/strong> <\/span>and several have been identified as probable human carcinogens. Their presence in pharmaceutical products has become a major regulatory concern since the discovery of NDMA contamination in&nbsp;<\/span>Valsartan<\/strong><\/span> products in 2018, which resulted in multiple product recalls worldwide.<\/span><\/p><h2>2. Nitrosamine Formation in APIs and Pharmaceutical Excipients<\/strong><\/span><\/h2>Nitrosamine formation requires three fundamental elements:<\/span><\/p><ul><li>An amine source<\/span><\/li><li>A nitrosating agent (typically nitrite)<\/span><\/li><li>Suitable reaction conditions such as moisture, temperature, and pH<\/span><\/li><\/ul>In pharmaceutical manufacturing, nitrosamines are not intentionally introduced. Instead, they may be generated during API synthesis, excipient manufacturing, formulation, or storage.<\/span><\/p><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/Tin kỹ thuật\/Nitrosamine flowchart.jpg\" alt=\"\"><\/figure><h3>a. API synthesis<\/strong><\/span><\/h3>API manufacturing processes frequently involve amines, amide-containing reagents, or nitrite salts. When these substances are present simultaneously under favorable conditions, nitrosamines may form as process-related impurities.<\/span><\/p>Common precursors include:<\/span><\/p><ul><li>Dimethylamine<\/span><\/li><li>Diethylamine<\/span><\/li><li>Triethylamine<\/span><\/li><li>Sodium nitrite<\/span><\/li><li>Potassium nitrite<\/span><\/li><\/ul>For example: <\/span>Dimethylamine + Nitrite → NDMA.<\/strong><\/span> <\/strong>This reaction pathway was identified as one of the primary sources of nitrosamine contamination in several sartan APIs.<\/span><\/p><h3>b. Recovered solvents<\/strong><\/span><\/h3>Recovered or recycled solvents may contain residual amines or trace levels of nitrosamines. Without adequate purification and process control, repeated solvent reuse can increase nitrosamine levels during API manufacturing.<\/span><\/p><h3>c. Nitrite impurities in raw materials<\/strong><\/span><\/h3>Trace nitrite may be introduced through: <\/span>Purified water, inorganic reagents, pharmaceutical excipients, synthetic intermediates. <\/strong><\/span>Although typically present at ppm or ppb levels, nitrite impurities may react with susceptible amines over time to generate nitrosamines.<\/span><\/p><h3>d. API degradation<\/strong><\/span><\/h3>Certain APIs containing secondary or tertiary amine structures may generate nitrosamines during storage. Factors influencing degradation include: Elevated temperature, High humidity, Nitrite contamination. Nitrosamine formation through degradation has been reported for APIs such as&nbsp;<\/span>Ranitidine<\/strong><\/span> and&nbsp;<\/span>Nizatidine<\/strong>.<\/span><\/p><h2>3. Pharmaceutical Materials Associated with Nitrosamine Risk<\/strong><\/span><\/h2><h3>a. Active Pharmaceutical Ingredients (APIs)<\/strong><\/span><\/h3>APIs containing secondary or tertiary amine functionalities generally present a higher risk for nitrosamine formation. Examples include: Metformin, Ranitidine, Nizatidine, Doxylamine, Varenicline, Valsartan, Losartan, Irbesartan<\/span><\/p><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/Tin kỹ thuật\/Nitrosamine in Active.jpg\" alt=\"\"><\/figure><h3>b. Pharmaceutical Excipients<\/strong><\/span><\/h3>Although excipients are not typically direct sources of nitrosamines, some may contribute to nitrosamine formation. Potential risk factors include:<\/span><\/p><ul><li>Nitrite-containing excipient:<\/strong><\/span> <\/strong>Nitrite impurities may be present at trace levels depending on the manufacturing process and raw material source.<\/span><\/li><li>Amine-containing excipients: <\/strong><\/span>Excipients containing amine functionalities may react with nitrite under suitable conditions to generate nitrosamines.<\/span><\/li><\/ul><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/Tin kỹ thuật\/Nitrosamine in Excipients_.jpg\" alt=\"\"><\/figure><h2>4. Regulatory Limits for Nitrosamine Impurities<\/strong><\/span><\/h2>Global regulatory agencies, including the FDA and EMA, have established acceptable intake (AI) limits for nitrosamine impurities based on toxicological risk assessment. The acceptable intake limits for commonly encountered nitrosamines are summarized in the table below. <\/span>Note:<\/strong><\/span> 1 ng = 10⁻⁶ mg. For the latest acceptable intake limits, refer to the<\/span>&nbsp;CDER Nitrosamine Impurity Acceptable Intake Limits<\/strong> <\/span>guidance.<\/span><\/p><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/Tin kỹ thuật\/Nitrosamine impurities.jpg\" alt=\"\"><\/figure>","image_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/images\/AVATAR%20BIORICHGROUP%20-%20TIN%20K%E1%BB%B8%20THU%E1%BA%ACT.jpg","image_thumb_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/thumb_images\/AVATAR%20BIORICHGROUP%20-%20TIN%20K%E1%BB%B8%20THU%E1%BA%ACT.jpg","tags":["Nitrosamine","Pharmaceutical Impurities","API","Excipients","NDMA","NDEA","Genotoxic Impurities","Pharmaceutical Raw Materials","Drug Safety","Quality Control","Regulatory Affairs","ICH M7","FDA","EMA"],"count_view":43,"seo_name":"what-is-nitrosamine-risks-of-nitrosamine-impurities-in-pharmaceutical-raw-materials","date_update":1783585620,"date_created_format":1783593944,"meta_title":"What Is Nitrosamine? Risks in Pharmaceutical Raw Materials | BIORICH","meta_desc":"Learn what nitrosamines are, how they form in APIs and excipients, the associated risks, and current regulatory limits for pharmaceutical raw materials.","meta_keyword":"nitrosamine,nitrosamine impurities,nitrosamine in pharmaceuticals,pharmaceutical impurities,nitrosamine in APIs,nitrosamine in excipients,NDMA,NDEA,genotoxic impurities","qr_code":"https:\/\/www.biorichgroup.com\/what-is-nitrosamine-risks-of-nitrosamine-impurities-in-pharmaceutical-raw-materials"},{"id":749932,"name":"Sodium Hydroxide – International Standard Alkalizing and pH Adjusting Excipient","desc":"Sodium Hydroxide from Sujata Nutri-Pharma Pvt. Ltd. (India). Premium pharmaceutical-grade raw material, applied as an alkalizing agent and pH adjuster in pharmaceutical formulations. Contact Biorich now!<\/p>","content":"<figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/Sodium Hydroxide – International Standard Alkalizing and pH Adjusting Excipient(1).jpg\"><\/figure><h2>1. General Introduction to Sodium Hydroxide<\/h2>Sodium Hydroxide (commonly known as Caustic Soda) is a strong inorganic base (alkali) that plays a vital role in the pharmaceutical and cosmetic industries. This active ingredient is primarily used as a pH-adjusting excipient and alkalizing agent to create a stable environment for pharmacological active ingredients, optimizing drug solubility and absorption.<\/p>The raw material is manufactured by Sujata Nutri-Pharma Pvt. Ltd. (India), a reputable manufacturer with international quality certifications. With a strict quality control process, Sujata Nutri-Pharma's Sodium Hydroxide achieves high purity, strictly limits heavy metal impurities, and fully meets the most stringent global pharmacopeial standards.<\/p><h2>2. Raw Material Information<\/h2><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/2(25).png\"><\/figure><ul><li>Material Name<\/strong><\/span>:<\/strong> Sodium Hydroxide \/ Caustic Soda<\/li><li>Manufacturer<\/strong><\/span>:<\/strong> Sujata Nutri-Pharma Pvt. Ltd.<\/li><li>Origin<\/strong><\/span>:<\/strong> India<\/li><li>Material Group<\/strong><\/span>:<\/strong> Pharmaceutical Excipients.<\/li><li>Function<\/strong><\/span>:<\/strong> Acid-base (pH) adjuster, alkalizing agent, reaction catalyst.<\/li><li>Chemical Composition<\/strong><\/span>:<\/strong> Molecular formula NaOH.<\/li><li>Form<\/strong><\/span>:<\/strong> Pellets, flakes, or white granules. Highly hygroscopic and readily absorbs carbon dioxide (CO2) from the air.<\/li><li>Solubility<\/strong><\/span>:<\/strong> Very soluble in water (highly exothermic upon dissolution), soluble in alcohol (ethanol, methanol).<\/li><li>Quality Standards<\/strong><\/span>:<\/strong> Complies with United States Pharmacopeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), or Indian Pharmacopoeia (IP) standards.<\/li><\/ul><h3>The material is strictly controlled for:<\/h3><ul><li>Purity<\/strong><\/span>:<\/strong> NaOH content meets strict pharmacopeial regulations, ensuring it is free from harmful impurities.<\/li><li>Heavy Metals and Carbonates Limits<\/strong><\/span>:<\/strong> Strict control of arsenic, iron, aluminum indicators, and sodium carbonate (Na2CO3) content generated by exposure to air, ensuring absolute safety for medical preparations.<\/li><\/ul><h2>3. Advantages of Sujata Nutri-Pharma's Sodium Hydroxide<\/h2><ul><li>Powerful Alkalizing Performance<\/strong><\/span>:<\/strong> Only a very small amount is needed to adjust and achieve the desired pH range, saving formulation space for other active ingredients.<\/li><li>High Purity and Safety<\/strong><\/span>:<\/strong> The purification process completely removes harmful impurities, meeting applications requiring high safety such as infusions and eye drops.<\/li><li>Reasonable Cost - Stable Supply<\/strong><\/span>:<\/strong> Manufactured in India by Sujata Nutri-Pharma, offering optimal competitive pricing, providing an effective solution for manufacturing plants to optimize production costs.<\/li><\/ul><h2>4. Applications of Sodium Hydroxide<\/h2><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/3(26).png\"><\/figure><h3>In Pharmaceuticals and Healthcare<\/strong><\/h3><ul><li>pH Adjustment for Injectables and Liquid Medications<\/strong><\/span>:<\/strong> Widely used in formulations of infusion solutions, eye drops, and ear drops to neutralize acidic environments, bringing the pH to physiologically compatible levels, reducing irritation during use.<\/li><li>Alkalizing Agent for Salt Formation<\/strong><\/span>:<\/strong> Reacts with weakly acidic active ingredients to form sodium salts that are more soluble in water (e.g., forming sodium salts of antibiotics, painkillers).<\/li><li>Manufacturing of Other Excipients<\/strong><\/span>:<\/strong> Participates in the synthesis of other pharmaceutical excipients and active ingredients due to its strong base catalytic properties.<\/li><\/ul><h3>In Cosmetics and Personal Care<\/strong><\/h3><ul><li>Saponification<\/strong><\/span>:<\/strong> An indispensable component in the saponification reaction of oils and fats to produce bar soaps and body washes.<\/li><li>Cosmetic pH Balancing<\/strong><\/span>:<\/strong> Used in creams, lotions, and skin gels to adjust the pH to suit the skin (often combined with weak acids to create a buffer system).<\/li><\/ul><h2>5. Commercial Products Using Sodium Hydroxide<\/h2><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/4(25).png\"><\/figure><figure class=\"image\"><img src=\"\/datafiles\/88336\/upload\/images\/2026-07\/5(23).png\"><\/figure><h2>6. Product Contact Information<\/h2>For further information on the supply chain, technical specifications of Sodium Hydroxide, or to place an order, please contact us:<\/p><ul><li>Consultation Hotline:<\/strong> +84 (0) 834 560 500<\/li><li>Email:<\/strong> director@biorichgroup.com<\/li><li>Website:<\/strong> <a href=\"https:\/\/www.google.com\/search?q=https%3A%2F%2Fwww.biorichgroup.com\">www.biorichgroup.com<\/a><\/li><li>Sample\/COA Request:<\/strong> Please contact us via email to request a sample and the latest Certificate of Analysis (COA) for the raw material from the manufacturer, Sujata Nutri-Pharma Pvt. Ltd.<\/li><\/ul>","image_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/images\/Avatar%20s%E1%BA%A3n%20ph%E1%BA%A9m\/Sodium%20Hydroxide%20%E2%80%93%20International%20Standard%20Alkalizing%20and%20pH%20Adjusting%20Excipient.jpg","image_thumb_url":"https:\/\/www.biorichgroup.com\/datafiles\/88336\/upload\/thumb_images\/Avatar%20s%E1%BA%A3n%20ph%E1%BA%A9m\/Sodium%20Hydroxide%20%E2%80%93%20International%20Standard%20Alkalizing%20and%20pH%20Adjusting%20Excipient.jpg","tags":["Sodium Hydroxide","alkalizing excipient","Sujata NutriPharma","pH adjuster","pharmaceutical raw material"],"count_view":15,"seo_name":"sodium-hydroxide-international-standard-alkalizing-and-ph-adjusting-excipient","date_update":1783567560,"date_created_format":1783568702,"meta_title":"Sodium Hydroxide","meta_desc":"Sodium Hydroxide from Sujata Nutri-Pharma Pvt. Ltd. (India). Premium pharmaceutical-grade raw material, applied as an alkalizing agent and pH adjuster in pharmaceutical formulations. 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