Excipient
ICH-Q7 GMP Manufactured ProductMES, Monohydrate, GMP Excipient Grade
Product Code: MESM-3220 | Previously: ME3220
Intended For Use In Pharmaceutical GMP Processes/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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99.0% min. | |||
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0.005% max. | |||
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Colorless | |||
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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 - 10% | |||
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3.1 - 3.5 | |||
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2.5 – 4.5 | |||
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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. | |||
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2 ppm max. 2 ppm max. 2 ppm max. 2 ppm max. |
| 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
- Stability Report
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
- Latex Statement
MESM-3220
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-3220 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-3220 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-3220 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