MOLACID® PROL

L-Proline

(Stabilizer)

l-proline-bp
MOLACID® PROL is an organic compound, is also known as L-Proline. It occurs as white or almost white, crystalline powder or colourless crystals. It is a natural amino acid used in the pharmaceutical industry as a stabilizer, excipient and chemical building block for medications.

MOLACID® PROL

by Muby Chem

l-proline-bp-prol

L-Proline

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

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

Applications: MOLACID® PROL is a naturally occurring amino acid used in the pharmaceutical industry as a stabilizer, excipient and chemical building block for pharmaceutical formulations and APIs. it can support formulation performance and product stability in tablets, capsules, powders and liquid preparations. It is also used as a chemical building block or intermediate for the synthesis of pharmaceutical compounds and biologically active molecules. depending on the specific amino acid and grade, it may be used in oral dosage forms, injectable solutions and parenteral nutrition formulations.

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

MOLACID® PROL TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 147-85-3
2 Molecular Formula C5H9NO2
3 Molecular Weight 115.1 g/mol

SPECIFICATION

#TESTSPECIFICATION - BP
1 Appearance It occurs as white or almost white, crystalline powder or colourless crystals.
2 Identification
Test (A)
Test (B)
Test (C)
(A) Specific optical rotation: − 86.0 to − 84.0 (dried substance).
(B) Infrared absorption spectrophotometry.
(C) Thin-layer chromatography.
3 Solubility It is very soluble in water, freely soluble in ethanol (96%).
4 Appearance of solution Solution S is clear and colourless.
5 Specific optical rotation Between − 86.0 to − 84.0 (dried substance).
6 Ninhydrin-positive substances
(A) Any ninhydrin-positive substance
(B) Total
(A) Not more than 0.2%.
(B) Not more than 0.5%.
7 Chlorides Not more than 200 ppm.
8 Sulfates Not more than 300 ppm.
9 Ammonium Not more than 0.02%.
10 Iron Not more than 10 ppm.
11 Loss on drying Not more than 0.5%.
12 Sulfated ash Not more than 0.1%.
13 Assay Not less than 98.5% to not more than 101.0% (dried substance).

PACKAGING

MOLACID® PROL 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. Preserved in well-closed containers.

ACCREDITATIONS

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

Disclaimer

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