MOLACID® GLY

Glycine

(Buffering Agent / Stabilizer)

glycine-bp
MOLACID® GLY is an organic compound. It is also known as Glycine with molecular formula C2H5NO2. It occurs as a white or almost white crystalline powder. MOLACID® GLY a simple amino acid used in pharmaceutical formulations primarily as an excipient, stabilizer and buffering agent.

MOLACID® GLY

by Muby Chem

glycine-bp

Glycine

Muby Chem operates a state-of-the-art manufacturing facility producing Glycine known for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.

Our advanced technology ensures the production of Glycine with exceptional purity and quality making it an ideal choice for use in the pharmaceutical industry.

Applications: MOLACID® GLY is used in pharmaceutical formulations as an excipient, stabilizer, buffering agent and formulation aid. It is used in tablets, capsules, oral powders, liquid preparations and injections, depending on formulation requirements. It can also function as a tonicity-adjusting agent in certain injectable and parenteral formulations. It is also used in protein, amino-acid and lyophilized formulations to improve the stability of sensitive ingredients. It helps maintain pH, stability and compatibility of active pharmaceutical ingredients (APIs).

We follow Good Manufacturing Practices (GMP) and adhere to international regulatory standards to ensure quality consistency with continuous supply.

MOLACID® GLY TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 56-40-6
2 Molecular Formula C2H5NO2
3 Molecular Weight 75.1 g/mol

SPECIFICATION

#TESTSPECIFICATION - EP
1 Appearance It occurs as a white or almost white crystalline powder.
2 Identification
Test (A)
Test (B)
Test (C)
(A) Infrared absorption spectrophotometry.
(B) Thin-layer chromatography.
(C) The solution is violet with greenish-yellow fluorescence. After a few minutes, the colour becomes orange and then yellow and an intense fluorescence remains.
3 Solubility It is freely soluble in water, very slightly soluble in ethanol (96%).
4 Appearance of solution Solution S is clear and not more intensely coloured than reference solution Y7.
5 PH Between 5.9 to 6.4.
6 Related substances
(A) Impurities B, H, I
(B) Unspecified Impurities
(C) Total
(A) Not more than 0.10%.
(B) Not more than 0.10%.
(C) Not more than 0.2%.
7 Ninhydrin-positive substances
(A) Any ninhydrin-positive substance
(B) Total
(A) Not more than 0.10%.
(B) Not more than 1.0%.
8 Chlorides Not more than 75 ppm.
9 Ammonium Not more than 0.02%.
10 Loss on drying Not more than 0.5%.
11 Sulfated ash Not more than 0.1%.
12 Assay Not less than 98.5% to not more than 101.0% (dried substance).

PACKAGING

MOLACID® GLY is packed in HDPE bag or HDPE drum with double PE liners inside having bar-coded label and tamper-evident seal.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Preserve in well-closed containers at room temperature.

ACCREDITATIONS

fda
health canada
edqm1
edqm
sgs
ANVISA
sfda
saphra
tga
china
mhra
cdsco
who
eu
exci
ecovadis

Disclaimer

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