Product Overview
Glycine IP/BP/EP/USP API is a highly pure amino acid, which is made under controlled quality systems.
It is supplied in several pharmacopeial grades to satisfy the requirements of regulators all over the world.
This API ensures a consistent particle size, clear purity, and reliable compliance.
It works well for regulated pharmaceutical and industrial manufacturing worldwide.
Therapeutic Applications
Glycine IP/BP/EP/USP API is important for making sterile irrigant solutions.
It is also used in parenteral and enteral nutrition products and amino acid blends.
Its purity, stability, and compliance with pharmacopeial standards make it suitable for creating regulated products in different dosage forms.
Specification Parameters
The Glycine IP/BP/EP/USP API specifications describe in detail its identity, purity, and quality.
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Chemical Name (IUPAC): 2-aminoacetic acid
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CAS Number: 56-40-6
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Appearance: White or nearly white crystalline powder
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Identification Tests: FTIR comparison with a reference standard. TLC where needed
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Assay Method: HPLC or a validated titrimetric method, as detailed in the pharmacopeial monograph.
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Assay Content: Typically 98.5%–101.5% on an anhydrous basis
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pH (5% solution): Within the defined pharmacopeial range.
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Loss on Drying / Water Content: Not more than the specified pharmacopeial limit
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Related Substances / Impurities: Controlled limits for glycine-related compounds
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Residual Solvents: Complies with ICH solvent guidelines
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Elemental Impurities: Meet ICH Q3D requirements.
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Residue on Ignition: Within specified limits.
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Microbial Limits: Not applicable or meet the necessary criteria.
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Solubility: Dissolves well in water and has low solubility in alcohol.
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Regulatory Grade: Conforms to IP, BP, EP, and USP standards.
Packaging & Storage
Glycine IP/BP/EP/USP API is supplied in 25 kg drums.
It comes in HDPE bags, fiber drums, or rigid HDPE drums with liners inside.
Store the API in a cool, dry place with good ventilation. Keep it away from moisture and heat.
Why Choose Us
Actiza Industry offers high-quality Glycine API.
We focus on strong quality systems, adhere to global standards, and have a reliable supply network from India.
Quality Focus
Our Glycine API is made with strict quality controls. We follow IP, BP, EP, and USP standards.
The result is that each batch of pharmaceuticals is made to be chemically pure, stable, and of high quality.
Global Compliance
We help international markets by keeping all the regulatory paperwork in order.
This means sticking to pharmacopeial standards and tracking the origins of our products.
This allows customers to meet global registration and audit needs with ease and confidence.
Integrated Supply
We use backwards-integrated API operations and a strong vendor network.
This ensures we have steady availability, flexible order options, and easy logistics.
Such factors always guarantee a stable supply and a long-term, smooth operation of any business.
Customer Support
We’re a quick-response team that delivers reliable tech support. Timely delivery is our priority.
We’re also dedicated to building lasting relationships with our partners.
