1.04078

Gelatin

powder, EMPROVE^® ESSENTIAL, Ph. Eur., BP, NF

• Synonym(s): Gelatin
• CAS Number: 9000-70-8
• MDL number: MFCD00081638
• UNSPSC Code: 12352202
• EC Index Number: 232-554-6

Properties

• Agency: BP; NF; Ph. Eur.
• Quality Level: 500
• product line: EMPROVE^® ESSENTIAL
• form: coarse powder; powder
• potency: >5000 mg/kg LD₅₀, oral (Rat)
• pH: 3.8-7.6 (25 °C, 10 g/L in H₂O)
• application(s): pharmaceutical; semi-solid formulation; solid formulation
• storage temp.: 15-25°C

Description

General description

Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
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

Gelatin is a commonly used ingredient in both food and pharmaceutics. In pharmaceutical application, gelatin has been used primarily for solid oral dosage forms.

Legal Information

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

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

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: nwg