ICH Q7 GMP Manufactured Product
MES Monohydrate
LBLE*, GMP, Excipient
Product Code: MESM-3250
*Low Bioburden, Low Endotoxin
Minimum Order Quantity: 250kg
Lead Time (if no stock): 3-6 months

| ANALYSIS | SPECIFICATIONS | ||
|---|---|---|---|
|
< = 0.1000 a.u. |
||
|
White Crystals | ||
|
> = 99.5% | ||
|
< = 50 ppm | ||
|
Colorless | ||
| Endotoxin | < 50 EU/g | ||
|
None Detected None Detected None Detected |
||
|
Conforms to Reference Standard | ||
| Loss on Drying, 130°C | 7 - 9% | ||
|
< = 100 CFU/g < = 100 CFU/g |
|||
|
3.1 – 3.5 | ||
|
2.5 – 4.0 | ||
|
5.9 – 6.3 |
||
|
< = 0.05% | ||
|
Passes Test | ||
|
< = 50 ppm | ||
|
< = 1.5 ppm < = 9 ppm < = 70 ppm < = 0.2 ppm < = 0.5 ppm < = 30 ppm < = 110 ppm < = 2 ppm < = 0.5 ppm < = 25 ppm < = 0.3 ppm < = 150 ppm < = 2 ppm < = 60 ppm < = 1 ppm |
||
| Water, KF | 7.8 – 8.9% |
Printable Version
Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).
Refer to SDS.
10kg, 25kg, and 50kg
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.