ICH-Q7 GMP Manufactured Product
Trehalose Dihydrate is a non-reducing disaccharide used as an excipient in biotherapeutic applications. Its primary purpose is to protect the protein drug substance both in the liquid and frozen state. It provides tonicity, stabilization, cryo-protection and lyo-protection. Trehalose is superior to other sugars due to the rigidity of the alpha 1,1 bond. Trehalose is also more stable under high temperature and acidic conditions. Due to its non-reducing end, Trehalose does not react with other excipients such as amino acids or aldehydes.
CAS #: 6138-23-4
Formula: C12H22O11 • 2H2O
Sol. In H2O (g/L): 689
F.W.: 378.33 g/mol.
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NF COMPENDIA |
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ANALYSIS |
SPECIFICATIONS |
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398.0% – 101.0% | |||
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≤ 0.0125% |
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≤ 0.033 ≤ 0.067 |
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3≤ 0.3 EU/g |
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Conforms to Standard |
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Passes Test | |||
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Passes Test | |||
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Absent/g Absent/10g ≤ 50 CFU/g ≤ 20 CFU/g |
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≤ 0.005% |
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+197° to +201° |
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4.5 - 6.5 |
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≤ 0.5% ≤ 0.5% |
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≤ 0.1% |
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Passes Test | |||
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≤ 0.0200% |
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9.0% to 11.0% |
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EP COMPENDIA |
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ANALYSIS |
SPECIFICATIONS |
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398.0% – 101.0% | |||
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Clear, colorless |
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≤ 0.0125% |
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3≤ 0.3 EU/g |
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Conforms to Standard |
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Passes Test | |||
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Passes Test | |||
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≤ 0.5% ≤ 0.2% ≤ 0.2% ≤ 1.0% |
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Absent/g Absent/10g Absent Absent ≤ 50 CFU/g ≤ 20 CFU/g |
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4.5 - 6.5 |
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Passes Test |
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+197° to +201° |
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≤ 0.1% |
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≤ 0.0200% | |||
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9.0% to 11.0% |
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JP COMPENDIA |
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ANALYSIS |
SPECIFICATIONS |
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98.0% – 101.0% | |||
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≤ 0.018% |
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Passes Test |
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≤ 5 ppm |
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Passes Test |
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Passes Test | |||
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Conforms to Standard |
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≤ 0.005% |
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+197° to +201° |
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4.5 – 6.5 |
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≤ 0.1% |
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≤ 0.5% ≤ 0.5% |
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≤ 0.0200% |
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9.0% to 11.0% |
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NON-COMPENDIAL ANALYSES |
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ANALYSIS |
SPECIFICATIONS |
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White to Off-White Crystalline Powder | ||
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≤ 200 ppm |
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≤ 250 ppm |
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≤ 50 ppm |
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ANALYSIS |
SPECIFICATIONS |
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≤ 50 ppb | ||
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≤ 50 ppb |
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≤ 50 ppb |
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≤ 100 ppb |
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Molybdenum |
≤ 100 ppb | ||
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Copper |
≤ 100 ppb | ||
| Chromium | ≤ 100 ppb | ||
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Iron |
≤ 100 ppb | ||
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Aluminum |
≤ 100 ppb | ||
| Zinc | ≤ 100 ppb |
1Alternate Validated Method
2Analyses are Harmonized
3Specifications is more stringent than Compendia Monograph
Bio Excipient Grade Trehalose Dihydrate TRED-3252 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Trehalose Dihydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
The recommended retest period for Trehalose, Dihydrate TRED-3252 is based on current available stability data in accordance with the Stability Testing Program.
10kg and 25kg pails.
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.