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1.02144

SAFC

Calcium hydrogen phosphate

anhydrous, fine powder, EMPROVE® ESSENTIAL, Ph. Eur., BP, USP, FCC, E 341(ii)

Pharma Manufacturing

Synonym(s):

Calcium hydrogen phosphate, Calcium orthophosphate, Calcium phosphate dibasic

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About This Item

Empirical Formula (Hill Notation):
HCaO4P
CAS Number:
Molecular Weight:
136.06
MDL number:
UNSPSC Code:
12352302
E Number:
E341 (ii)
EC Index Number:
231-826-1

Agency

BP
Ph. Eur.
USP

Quality Level

reg. compliance

FCC

product line

EMPROVE® ESSENTIAL

form

fine powder

potency

10000 mg/kg LD50, oral (Rat)
>7940 mg/kg LD50, skin (Rabbit)

particle size

(see specification)

pH

7 (20 °C, 10 g/L in H2O, suspension)

mp

370 °C (decomposition)

density

2.89 g/cm3 at 20 °C

application(s)

pharmaceutical
semi-solid formulation
solid formulation

storage temp.

2-30°C

InChI

1S/Ca.H3O4P/c;1-5(2,3)4/h;(H3,1,2,3,4)/q+2;/p-2

InChI key

FUFJGUQYACFECW-UHFFFAOYSA-L

General description

To address challenges of solid formulation manufacturing, we have developed a comprehensive product portfolio to meet with your solid dosage needs in mind. Although solid dose formulations are one of the the most established dosage forms in the pharmaceutical market, the complexity of manufacturing final drug products is becoming more and more challenging. API stability, release kinetics and bioavailability limitations, such as low API solubility, are just a few of many critical obstacles on the way to the market.
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

Calcium hydrogen phosphate is a commonly used ingredient in both food and pharmaceutics. In pharmaceutical applications, calcium hydrogen phosphate is primarily used as a filler/binder.

Legal Information

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

Storage Class Code

13 - Non 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

CO1E1021441000:
1021449029:
1021449026:
1021449500:
1021449025:
AR11021449029:
1021449029BWT:
1021449026BWT:
CO1E1021449029:
1021440000:
1021441000:
1021449999:
1021449028:


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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