Excipient
ICH-Q7 GMP Manufactured ProductMES, Monohydrate, LBLE
GMP Excipient Grade
Low Bioburden, Low Endotoxin, GMP Manufactured
Product Code: MESM-3250
Intended For Use As An Excipient
MES Monohydrate is a zwitterionic buffer that is not absorbed through cell membranes and is virtually transparent in UV light. MES is a buffering agent used in many biological and biochemical applications. It is also used as a running buffer for denaturing gel electrophoresis. The characteristics of low UV absorptivity, minimal reactivity, stable pH and solubility in water allow MES Monohydrate Excipient to be used as a Good’s buffer.
Product Specifications
| ANALYSIS | SPECIFICATIONS | |||
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0.1000 a.u. max. 0.1000 a.u. max. |
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White / Crystals | |||
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≥ 99.5% min. | |||
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0.005% max. | |||
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Colorless | |||
| Endotoxin | < 50 EU/g | |||
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None Detected None Detected None Detected |
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2 ppm max. | |||
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Passes Test | |||
| Loss on Drying @ 130°C | 7 - 9% | |||
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3.1 – 3.5 | |||
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2.5 – 4.0 | |||
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5.9 – 6.3 |
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0.05% max. | |||
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Passes Test | |||
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0.005% max. | |||
| TAMC | ≤ 100 CFU/g | |||
| TYMC | ≤ 100 CFU/g | |||
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≤ 0.2 ppm ≤ 0.5 ppm ≤ 1.5 ppm ≤ 0.3 ppm ≤ 0.5 ppm ≤ 1 ppm ≤ 2 ppm ≤ 25 ppm ≤ 9 ppm ≤ 70 ppm ≤ 150 ppm ≤ 30 ppm ≤ 60 ppm ≤ 110 ppm ≤ 2 ppm |
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| Water (by Karl Fischer) | 7.8 – 8.9% |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
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| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient |
| LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin). LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP Report - Stroudsburg
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Degradation and Impurity
- LBLE Statement
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
- Latex Statement
- Real-Time Stability Report
MESM-3250
CAS #: 145224-94-8
Formula: C6H13NO4S·H2O
Sol. In H2O (g/L): 310
F.W.: 213.25 g/mol
pH @ 20°C: 2.5 - 4.5
Useful pH: 5.5 - 6.7
pKa @ 20˚C: 6.1
General Product Description:
- The manufacturing of Bio Excipient Grade MES, Monohydrate
MESM-3250 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Excipient Grade MES, Monohydrate is cleaned in accordance with - BioSpectra’s Cleaning Validation Plan.
- MES is a White Crystalline product.
- Molecular Formula: C6H13NO4S·H2O
- Molecular Weight: 213.25 g/mol.
- CAS Number: 145224-94-8.
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all MES, Monohydrate MESM-3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
- MES, Monohydrate manufactured at BioSpectra and any raw materials used in the manufacture of MES, Monohydrate at BioSpectra are not subject to genetic modification.
- Synonyms: 2-(N-Morpholino)ethanesulfonic acid, 4-Morpholineethanesulfonic acid monohydrate.
GMP Compliance:
Bio Excipient Grade MES, Monohydrate MESM-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of MES, Monohydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for MES, Monohydrate is two years from the date of manufacture.
Storage and Shipping Conditions:
Ship and Store in ambient temperature.
Package Sizes:
10kg, 25kg and 50kg pails.
Additional Packaging Information
https://www.biospectra.us/technical/packaging