DiTech DiFunctional G

Identification

Chemical Name

α-D-Glucose monohydrate,

Dextrose Monohydrate

Categories

Technologies → Pharmaceuticals & Nutraceuticals → Product Families → Pharmaceutical Actives & Precursors → Active Pharmaceutical Ingredients (APIs)

Markets → Healthcare & Pharma → Applications → Drug Delivery & Care Solutions → Dialysis

Technologies → Pharmaceuticals & Nutraceuticals → Product Families → Excipients → Formulation & Processing Aids

Markets → Healthcare & Pharma → Applications → Drug Delivery & Care Solutions → Parenteral

Applications

Dosage Form

Injectables

Benefits & Claims

Labeling Claims

Melamine-free,

Bovine Spongiform Encephalopathy (BSE)-free,

TSE-free,

Vegan,

Non-Hazardous,

Kosher,

Halal,

Pyrogen-free

Functions

Pharma & Nutraceuticals Functions

Osmotic Agent,

Isotonic Agent

Function

Osmotic Agent, Isotonic Agent

Packaging & Availability

Packaging Information

• ROQ Product Code: 493404
• Article (SKU) Code: 493404107E
• Package Size & Type: 15 kg PE lined cardboard box

Properties

Physical Form

Powder,

Solid

Note

• "EP" - stands for European Pharmacopeia
• "USP" - stands for USP Pharmacopeia
• "JP" - stands for JP Pharmacopeia
• (*) - Compliance data - Tests not performed
• (**) - Monitoring plan

Pyrogen Test (**)

COMPLIES (EP)

• Solute at 150 g/L
• Sterilized 10 mn at 110 D.C
• Injection 10 mL/Kg

Regulatory & Compliance

Certifications & Compliance

European Pharmacopeia (Ph. Eur.),

FDA Compliant,

United States Pharmacopeia (USP),

GMP,

Halal,

ISO 9001,

Kosher,

DMF Type II,

Indian Pharmacopeia

Chemical Inventories

AICS (Australia),

DSL (Canada),

EINECS (EU),

ENCS (Japan),

IECSC (China),

INSQ (Mexico),

ISHL (Japan),

KECI (Korea),

NZIoC (New Zealand),

PICCS (Phillipines),

TSCA (USA),

TCSI (Taiwan)

Grade

Pharma Grade

Conformity

Conforms to the requirements of the current monograph

• European Pharmacopeia (EP) GLUCOSE MONOHYDRATE (0178)
• US Pharmacopeia (USP) DEXTROSE
• Japanese Pharmacopeia (JP) Glucose Hydrate

Please contact us for any statement regarding compliance to the General Chapters (elemental impurities, residual solvents, organic volatile impurities, metal catalyst, metal reagent).

Storage & Handling

Storage

Retest Date Manufacturing date + 2 years, in its unopened packaging.

• We recommend to preserve the product in its unopened original packaging, preferably protected from wide variations of temperature and humidity.
• Upon opening, use the product as quickly as possible to prevent moisture regain.

Technical Details & Test Data

Test Data

• Intended for use in manufacture of parenteral dosage forms.
• Methods used by Roquette may be the Pharmacopeia methods or alternative validated methods which have been compared to the Pharmacopeia methods.