Chemische Werke Hommel GmbH & Co. KG  

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Im Wirrigen 25
D-45731 Waltrop
Tel.: +49 2309 60699-0
Fax: +49 2309 60699-30
www.hommel-pharma.com
info@hommel-pharma.com

Specification

Concerning Product:
Article number 137086NPU
Trade name / designation / denomination Vitamin B5 (Calcium D-pantothenate) USP
CAS number 137-08-6
Other names / synonyms•CALCIUM DL-PANTOTHENATE; •Calcium DL-Pantothenate; •Calcium Pantothenate, FCC; •Calcium Pantothenate, Powder, USP; •Calcium Pantothenate, Ultrapure; •Calcium pantothenate; •D-PANTOTHENIC ACID; •D-Pantothenic acid hemicalcium salt; •DL-Pantothenic Acid Calcium Salt; •Vitamin B5;
EC number205-278-9
Customs tariff number / CN code / TARIC29362400
Molecular weight [g / mol]476,54
FormulaC18H32CaN2O10


Parameter Specification Unit

Organoleptic test
Appearance white granulate

Physical parameter
Acidity/Alkalinity complies
Loss on drying ≤ 5 %

Identity
Assay 98,0  –  102,0 %
Identification complies

Impurities
Heavy Metals (as Pb) ≤ 20 ppm

Residual Solvents
Residual solvents Methanol ≤ 3000

Elemental Impurities
Calcium (Ca) 8,2  –  8,6 %

Microbiological data
Escherichia Coli. not detectable in 1 g CFU/g
Salmonella not detectable in 10 g
Total Plate Count ≤ 1000 CFU/g
Yeast and Mould ≤ 200 CFU/g

Regulatory information:

Allergens statement: According to Annex II of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25th October 2011 and its amendment (EU) No 78/2014 on substances or products the above mentioned product does NOT cause allergies or intolerances and does NOT contain any allergens which have to be labelled according to these regulations.

BSE/TSE statement: Risk of BSE/TSE contamination can be excluded.

GMO statement: Genetic engineering:
For the above mentioned product there is no obligation of g.m.o. labelling as defined by the Regulations (EC) No 1829/2003 and 1830/2003 of the European Parliament and the Council of 22nd September 2003.


Supplemental information:

Shelf life: 36 month

Derivation: synthetic

Note: Traceability
According to Regulation (EC) No 178/2002 the traceability of the raw materials for the product is guaranteed one step backwards and of produced batches one step forward. All instructions, which are necessary to take these steps, are implemented in the Quality manual and management system according to IFS and BRC.

Storage conditions: Protect from light and store cool and dry in well-closed original packaging. The temperature should not exceed 25 °C.

Usage: The product is suitable for a vegetarian nutrition.
The product is suitable for a vegan nutrition.
The product is suitable for lactose intolerance diet.
The product is suitable for people with coeliac disease and sprue.
The product is in compliance with Jewish dietary laws.
The product is in compliance with Islamic dietary laws.


Chemische Werke Hommel GmbH & Co.KG
This document was generated electronically and is valid without signature.
Waltrop, 06. Dec. 2019
We only confirm that we took over the data from our supplier accordingly. Despite careful working, errors in the takeover are not totally excluded. Some or all parts off the document may be translated due to our best knowledge from the original to give a better understanding. If you have any questions about specific details, please call us directly. Unless otherwise marked, these data do not originate from us and have not been tested by us on the correctness. The above information corresponds to the present state of our knowledge and is intended as a general description of our products and their possible applications. We make no warranties, expressed or implied, as to the information's accuracy, adequacy, sufficiency or freedom from defect and assumes no liability in connection with any use of this information. Any user of this product is responsible for determining the suitability of our products for its particular application. The foregoing information does not absolve the buyer of its own tests. Observing existing laws and regulations, is the responsibility of the buyer of our product. Nothing included in this information waives any of our General Terms and Conditions of Sale, which control unless it agrees other in writing. Any existing intellectual/industrial property rights must be observed. Due to possible changes in our products and applicable national and international regulations and laws, the status of our products could change. Material Safety Data Sheets providing safety precautions, that should be observed when handling or storing our products, are available upon request and are provided in compliance with applicable law. The user should obtain and review the applicable Material Safety Data Sheet information before handling any of these products. For additional information, please contact us.


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