MOLCHLOR™ CHO

Choline Chloride

(Nutrition Support)

choline-chloride-usp
MOLCHLOR™ CHO , an organic compound with the chemical formula C₅H₁₄ClNO, is widely recognized as Choline Chloride. It is primarily used in parenteral applications as an intravenous (IV) therapy to prevent or treat choline deficiency and associated hepatic steatosis (fatty liver) in patients requiring parenteral nutrition (PN).

MOLCHLOR™ CHO

by Muby Chem

choline-chloride-usp-intro

Choline Chloride

Muby Chem operates a state-of-the-art facility dedicated to producing high-purity Choline Chloride, widely recognized for its efficacy in pharmaceutical applications.

Our cutting-edge technology ensures the production of high-quality Choline Chloride, meeting the highest standards for performance and consistency.

Applications: MOLCHLOR® CHO is used in Total Parenteral Nutrition (TPN) formulations, particularly in long-term use, to prevent or correct choline deficiency. Choline deficiency can lead to hepatic steatosis (fatty liver), liver dysfunction, and muscle damage.

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

MOLCHLOR™ CHO TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 67-48-1
2 Molecular Formula C5H14ClNO
3 Molecular Weight 139.62 g/mol

SPECIFICATION

#TESTSPECIFICATION - USP
1 Characters It occurs as a colorless or white crystals or crystalline powder. Hygroscopic
2 Identification
Test (A)
Test (B)
Teat (C)
(A) Infrared Spectroscopy
(B) It gives reaction of chloride.
(C) Specified test
3 Solubility Soluble in alcohol and in water.
4 pH 4.0 to 7.0.
5 Residue on ignition Not more than 0.05%.
6 Arsenic Not more than 2 ppm.
7 Lead Not more than 0.3 ppm.
8 Limit of total amines Not more than 10 µg/g.
9 Water Not more than 0.5%
10 Microbial limit test
(A)TAMC
(B)TYMC
(A) Not more than 1000 cfu/g
(B) Not more than 100 cfu/g
11 Bacterial Endotoxins Not more than 5 IU/mg
12 Related compounds
(A) Choline related compound A
(B) Any unspecified impurity
(C) Total impurities
(a) Not more than 0.1 %.
(b) Not more than 0.1 %.
(c) Not more than 0.5 %.
13 Assay
(A) Content of Choline

(B) Content of Chloride

(C) Content of Choline Chloride
(a) Not less than 72.2% and not more than 74.7% on the anhydrous basis
(b) Not less than 24.8% and not more than 25.8% on the anhydrous basis.
(c) Not less than 97.0% and not more than 100.5% on the anhydrous basis.

PACKAGING

MOLCHLOR® CHO 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. It is 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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