2021-05-26
D-(+)-Trehalose dihydrate 海藻醣 NF, Ph. Eur. for bioprocessing, suitable for use as excipient endotoxin tested 各廠牌 海藻醣,應有盡有,歡迎洽詢 Molecular Formula: C12H22O11·2H2O MDL Number:MFCD00071594 Molecular Weight: 378.33 g/mol CAS Number: 6138-23-4 Melting Pt: 97…99 °C   Storage Temperature: Ambient     Specification Test Results Assay (NF- Anhydrous basis, EP- Anhydrous substance) 97.0- 102.0% Appearance of solution (2.2.1 & 2.2.2) PASS Bacterial Endotoxins ≤ 2.5 EU/g Chloride221 ≤ 0.0125% Chlorides (2.4.4) ≤ 125 ppm Color and Clarity of Solution PASS Escherichia coli 62 ABSENT Heavy Metals 231 ≤ 5 ppm Identification A (USP, EP) PASS Identification B (USP, EP) PASS Identification C (USP, EP) PASS Microbial Contamination (2.6.12): TAMC ≤ 1000 CFU/g Microbial Contamination (2.6.12): TYMC ≤ 100 CFU/g Microbial Contamination (2.6.13): Escherichia coli ABSENT Microbial Contamination (2.6.13): Salmonella ABSENT Nitrogen Determination 461 ≤ 0.005% pH 791, (2.2.3) 4.5 - 6.5 Related Substances (NF) ≤ 0.5% Related Substances (NF- Disregard Limit) ≤ 0.1% Related Substances (EP- Impurities A,B) ≤ 0.5% Related Substances (EP- Total) ≤ 1.0% Related Substances (EP- Unspecified Impurities) ≤ 0.2% Residue after Ignition 281 ≤ 0.1% Salmonella 62 ABSENT Soluble Starch Test (NF, EP) PASS Specific Rotation 781S, (2.2.7) +197 - +201 Degrees Sulfated Ash (2.4.14) ≤ 0.1% Sulfate 221 ≤ 0.0200% Sulfates (2.4.13) ≤ 200 ppm Total Aerobic Microbial Count 61 ≤ 100 CFU/g Total Combined Molds and Yeasts Count 61 ≤ 100 CFU/g Water Determination 921, (2.5.12) 9.0 – 11.0%