MOLACID® HIS

Histidine

(Buffering Agent / Stabilizer)

histidine-ep
MOLACID® HIS is an organic compound, is also known as Histidine with molecular formula C6H9N3O2. It occurs as white or almost white, crystalline powder or colourless crystals. It is used as a vital pH buffering agent and stabilizer in protein-based biopharmaceutical formulations.


MOLACID® HIS

by Muby Chem

histidine-ep-his

Histidine

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

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

Applications: MOLACID® HIS is widely used in pharmaceutical and biopharmaceutical formulations as a Buffering Agent/Stabilizer. It helps maintain the desired pH and supports the stability and solubility of sensitive active ingredients and biological molecules. Histidine may be incorporated into suitable formulations such as tablets, capsules, oral powders, oral solutions, and lyophilized products, depending on the intended application. It helps maintain the quality, potency and stability of biopharmaceutical products during storage and reconstitution.

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

MOLACID® HIS TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 71-00-1
2 Molecular Formula C6H9N3O2
3 Molecular Weight 155.15 g/mol

SPECIFICATION

#TESTSPECIFICATION - EP
1 Appearance It occurs as white or almost white, crystalline powder or colourless crystals.
2 Identification
Test (A)
Test (B)
Test (C)
Test (D)
(A) Specific optical rotation: + 11.4 to + 12.4 (dried substance).
(B) Infrared absorption spectrophotometry.
(C) Thin-layer chromatography.
(D) An orange-red colour develops.
3 Solubility It is 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 BY7.
5 Specific optical rotation + 11.4 to + 12.4 (dried substance).
6 Ninhydrin-positive substances
(A) Any ninhydrin-positive substance
(B) Total
(A) For each impurity, 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® HIS 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.

ACCREDITATIONS

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

Disclaimer

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