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Safety Information

5.00111

SAFC

Cocarboxylase tetrahydrate

(thiamine pyrophosphate tetrahydrate), EMPROVE® API

Pharma Manufacturing

Synonym(s):

Cocarboxylase tetrahydrate

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About This Item

Empirical Formula (Hill Notation):
C12H18N4O7P2S · 4H2O
CAS Number:
68684-55-9
Molecular Weight:
496.37
UNSPSC Code:
12352107
EC Index Number:
205-230-7

Quality Level

600

product line

EMPROVE® API

form

solid

pH

2.4-3.2 (20 °C, 100 g/L in H2O)

solubility

55 g/L

bulk density

450 kg/m3

application(s)

liquid formulation
pharmaceutical
semi-solid formulation
solid formulation

storage temp.

2-25°C

InChI

1S/C12H18N4O7P2S.4H2O/c1-8-11(3-4-22-25(20,21)23-24(17,18)19)26-7-16(8)6-10-5-14-9(2)15-12(10)13;;;;/h5,7H,3-4,6H2,1-2H3,(H4-,13,14,15,17,18,19,20,21);4*1H2

InChI key

KLOLNRGPRQYTIW-UHFFFAOYSA-N

General description

We provide industry-leading production know-how and comprehensive regulatory support for high-quality APIs, backed by nearly 200 years of experience. From a complete portfolio of innovative folates to custom synthesis, our customized and scalable solutions meet your specific production needs. As part of our EMPROVE® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Cocarboxylase tetrahydrate Emprove® API is a source for Vitamin B1 for use in clinical nutrition, vitamin supplements and infusion for Vitamin B1 deficiency. Cocarboxylase Tetrahydrate (thiamine diphosphoric acid ester tetrahydrate) Emprove® API is manufactured according to ICH Q7 guidelines. An ASMF is available.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

Disclaimer

The substance 5.00111 has no REACH registration because the only supported use is the use in medicinal products for human or veterinary use or in food or feedingstuffs according to article 2 of the REACH Regulation (EC) No 1907/2006.

Storage Class Code

11 - Combustible Solids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

JAN Code

5001119999:
5001115003:
5001110100:
5001115000:
5001110000:
D5001110100BWT:

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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