MOLCAL™ FOL

Calcium Folinate

(Calcium supplement)

calcium-folinate-bp
MOLCAL™ FOL commonly known as Calcium Folinate, is the calcium salt of folinic acid, a reduced form of folic acid. It is widely used in the pharmaceutical industry as an active pharmaceutical ingredient (API) for folate replacement therapy, methotrexate rescue treatment, and in combination with fluorouracil in oncology applications.

MOLCAL™ FOL

by Muby Chem

calcium-folinate

Calcium Folinate

Muby Chem operates a state-of-the-art manufacturing facility producing high quality Calcium Folinate, known for its exceptional purity and effectiveness. This versatile compound is widely used across various industries, including pharmaceutical applications.

Our cutting-edge technology ensures the production of Calcium Folinate with exceptional purity and quality, making it an ideal choice for a variety of applications.

Application: MOLCALTM FOL is used as an active pharmaceutical ingredient in pharmaceutical formulations. It is indicated for folate replacement therapy, rescue treatment following high-dose methotrexate therapy, reduction of toxicity associated with folic acid antagonists, and as an adjunct to fluorouracil-based chemotherapy regimens. It is used in the manufacture of tablets, capsules, oral solutions, and injectable preparations.

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

MOLCAL™ FOL TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 2060570-47-8
2 Molecular Formula C20H21CaN7O7, xH2O
3 Molecular Weight 511.5 g/mol

SPECIFICATION

#TESTSPECIFICATION - BP
1 Appearance It occurs as White or light yellow, amorphous or crystalline, hygroscopic powder.
2 Identification
Test (A)
Test (B)
Test (C)
Test (D)
(A) Specific optical rotation
(B) Infrared absorption spectrophotometry
(C) Thin-layer chromatography
(D) It gives reaction (b) of calcium.
3 Solubility Sparingly soluble in water, practically insoluble in acetone and in ethanol (96 percent).
4 Appearance of solution Solution S is clear
5 pH 6.8 to 8.0
6 Specific Optical rotation + 14.4 to + 18.0
7 Absorbance Not more than 0.60
8 Ethanol Not more than 3.0%
9 Related substance
Impurity A, E, F
Unspecified impurities
Total Impurity
Not more than 0.3%
Not more than 0.20%
Not more than 1.5%
10 Chlorides Not more than 0.5%
11 Water 10.0 % to 17.0 %
12 Assay
Calcium Folinate
Calcium
Not less than 97.0 % to Not more than 102.0 %
Not less than 7.54 % to Not more than 8.14 %

PACKAGING

MOLCALTM FOL 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. In an airtight container, protected from light.

ACCREDITATIONS

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

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