Monothioglycerol CDMF Parentex

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1. General Introduction to Monothioglycerol CDMF PARENTEX

Monothioglycerol CDMF PARENTEX (also known as Thioglycerol / 3-mercapto-1,2-propanediol) is a high-quality antioxidant excipient that plays a crucial role in preventing the oxidative degradation of sensitive active pharmaceutical ingredients. Specifically, the PARENTEX product line is exclusively designed for sterile preparations (injectable drugs), with ultra-high purity and strict control over impurity limits, helping to maintain physicochemical stability and extend the shelf life of medications.

The raw material is manufactured byAceto Pharma (India) Pvt Ltd (India), a leading reputable manufacturer in India specializing in high-quality excipients and pharmaceutical ingredients. The product meets the most stringent standards of the pharmaceutical industry and is fully supported by DMF/CDMF (Chinese Drug Master File) documentation, providing absolute peace of mind for manufacturers of injectables, ophthalmic solutions, and premium liquid preparations.

2. Raw Material Information: Monothioglycerol CDMF PARENTEX

Material Name: Monothioglycerol CDMF PARENTEX (Thioglycerol)
Manufacturer: Aceto Pharma (India) Pvt Ltd
Origin: India
Material Category: Pharmaceutical Excipient / Antioxidant / Preservative.
Function: Acts as an antioxidant, protects oxidation-prone active ingredients from degradation, and maintains the color, stability, and shelf life of injectables or liquid solutions.
Chemical Composition: 3-mercapto-1,2-propanediol.
Physical Form: Viscous, clear liquid, colorless to slightly pale yellow, with a characteristic slight sulfide (mercaptan) odor.
Solubility: Very soluble in water, freely miscible with ethanol, practically insoluble in ether.
Quality Standards: Meets Parenteral Grade standards with complete CDMF documentation.

The material is strictly controlled for:

Purity & Assay: Ensures a very high standard of active ingredient content to maximize antioxidant efficacy at low concentrations.
Impurities & Heavy Metals Limits: Strict control of trace impurities and heavy metals to prevent undesirable catalyzed degradation reactions.
Bacterial Endotoxins: Subject to exceptionally strict control, ensuring absolute safety when applied in intravenous injectable dosage forms.

3. Outstanding Advantages of Monothioglycerol CDMF PARENTEX

Superior Antioxidant Protection: Effectively prevents the formation of free radicals and auto-oxidation processes, particularly effective for active ingredients prone to degradation in aqueous environments.
Parenteral-grade Purity: The PARENTEX line maximally removes impurities, ensuring a safe tolerance for parenteral administration without causing tissue irritation.
Flexible Compatibility: Highly compatible with various buffer solutions and other excipients, operating effectively across a wide pH range in pharmaceutical formulations.
Strong Registration Support: Comes with complete CDMF documentation, helping pharmaceutical companies shorten R&D timelines and easily pass regulatory approval processes.

4. Applications of Monothioglycerol CDMF PARENTEX

In Pharmaceuticals (Core Application)

Injections and Infusions: An essential antioxidant excipient in intravenous (IV) and intramuscular (IM) injection formulations, especially for sensitive APIs such as vitamins, hormones, anesthetics, or antibiotics.
Ophthalmic and Nasal Solutions: Protects active ingredients in sterile solutions for eye/nasal use, extending the shelf life after opening.
Oral Liquids: Stabilizes flavors and prevents discoloration in syrups or oral solutions.
Ointments and Topical Creams: Prevents the oxidation of water-soluble components in emulsion systems.

5. Commercial Products Using Monothioglycerol

6. Product Contact Information

For more information regarding the supply chain, technical specifications of Monothioglycerol CDMF PARENTEX, or to place an order, please contact us:

Consulting Hotline: +84 (0) 834 560 500
Email: director@biorichgroup.com
Website:www.biorichgroup.com
Sample/COA/CDMF Request: Please contact us via email to request testing samples, the latest Certificate of Analysis (COA), and the technical dossier (DMF) from the manufacturer, Aceto Pharma (India) Pvt Ltd.

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Monothioglycerol CDMF PARENTEX – Premium antioxidant excipient, optimizing API protection

1. General Introduction to Monothioglycerol CDMF PARENTEX

2. Raw Material Information: Monothioglycerol CDMF PARENTEX

The material is strictly controlled for:

3. Outstanding Advantages of Monothioglycerol CDMF PARENTEX

4. Applications of Monothioglycerol CDMF PARENTEX

In Pharmaceuticals (Core Application)

5. Commercial Products Using Monothioglycerol

6. Product Contact Information

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