Cholecalciferol Related Compounds & Impurities

Cholecalciferol (vitamin D3) is the naturally occurring form of vitamin D synthesised in skin on UV exposure and found in animal-source foods, converted to active calcitriol in the liver and kidney.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Cholecalciferol reference standards, pharmacopeial and non-pharmacopeial Cholecalciferol impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Cholecalciferol-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Cholecalciferol
Cholecalciferol EP Impurity B
Cholecalciferol EP Impurity A
Precalciferol
Calcifediol Monohydrate
Cholecalciferol EP Impurity D
Cholecalciferol EP Impurity E
Cholecalciferol EP Impurity C
24,25-Dihydroxy Vitamin D3
Vitamin D3 (100,000 IU/g)
Cholecalciferol EP Impurity F
Vitamin-D3 Octanoate
Vitamin-D3 Decanoate
Pre-vitamin-D3 Octanoate
Pre-Vitamin-D3 Decanoate
25-Hydroxyvitamin D3 3-Hemisuccinate
Cholecalciferol Impurity 1
1-Alpha-Hydroxy-Previtamin D3
Vitamin D3 Impurity 1
Vitamin D3 Impurity 2
Vitamin D3 Impurity 3
Vitamin D3(40000 IU/mg)
Preergocalciferol

Metabolites

3-epi-25-Hydroxy Vitamin D3

Isotope Labelled Compounds

Cholecalciferol-D6
1alphaHydroxyvitamin-D3
25-Hydroxy Vitamin D3-d6
Cholecalciferol-D7
Vitamin D3