MOLACID® HIS

Histidine

(Buffering Agent / Stabilizer)

histidine-usp
MOLACID® HIS is an organic compound, is also known as Histidine with molecular formula C6H9N3O2. It occurs as white, odorless crystals, having a slightly bitter taste. It is used as a vital pH buffering agent and stabilizer in protein-based biopharmaceutical formulations.

MOLACID® HIS

by Muby Chem

histidine-usp-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 - USP
1 Description It occurs as white, odorless crystals, having a slightly bitter taste.
2 Identification
Test (A)
(A) Infrared spectrophotometry.
3 Solubility It is soluble in water; very slightly soluble in alcohol; insoluble in ether.
4 Residue On Ignition Not more than 0.4%.
5 Chloride Not more than 0.05%.
6 Sulfates Not more than 0.03%.
7 Iron Not more than 30 ppm.
8 Related Compounds
(A) Individual impurities
(B) Total impurities
(A) Not more than 0.5%.
(B) Not more than 2.0%.
9 Optical Rotation Between +12.6° to +14.0°.
10 PH Between 7.0–8.5.
11 Loss On Drying It loses not more than 0.2% of its weight.
12 Assay Not less than 98.5% to not more than 101.5% on the dried basis.

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. Preserved in well-closed containers.

ACCREDITATIONS

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

Disclaimer

This document and any information provided herein does not constitute a legally binding obligation of Muby Chem and has been prepared in good faith and is believed to be accurate as of the date of issuance. Unless expressly agreed otherwise in writing in a supply contract or other written agreement between you and Muby Chem:

  1. To the fullest extent not prohibited by the applicable laws, MUBY CHEM EXPRESSLY DISCLAIMS ALL REPRESENTATIONS, WARRANTIES, CONDITIONS OR GUARANTEES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, BY FACT OR LAW, INCLUDING ANY IMPLIED WARRANTIES, REPRESENTATIONS OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY, NON-INFRINGEMENT, AND ANY REPRESENTATIONS, WARRANTIES, CONDITIONS OR GUARANTEES, ARISING FROM STATUTE, COURSE OF DEALING OR USAGE OF TRADE AND MUBY CHEM HEREBY EXPRESSLY EXCLUDES AND DISCLAIMS. ANY LIABILITY RESULTING FROM OR IN CONNECTION WITH THIS DOCUMENT OR ANY INFORMATION PROVIDED HEREIN, including, without limitation, any liability for any direct, consequential, special, or punitive damages relating to or arising therefrom, except in cases of (i) death or personal injury, (ii) Muby Chem or its agents and assistants willful misconduct, fraud or fraudulent misrepresentation or (iii) any matter in respect of which it would be unlawful for Muby Chem to exclude or restrict liability under the applicable laws;
  2. Any information provided herein can be changed at Muby Chem sole discretion anytime and neither this document nor the information provided herein may be relied upon to satisfy any obligations you may have to undertake your own inspections and evaluation.
  3. Muby Chem rejects any obligation to, and will not, automatically update this document and any information provided herein, unless required by applicable law; and
  4. You are responsible for confirming that you have retrieved the most current version of this document from Muby Chem.