8671-MSDS .pdf
PDF 458 KB Posted
- Attached to
- Vialing of Monoclonal Antibody
- Solicitation number
- NB645030-25-01699
About this file
This document is a Reference Material (RM) specification sheet for NIST mAb, Humanized IgG1κ Monoclonal Antibody (RM 8671), issued by the National Institute of Standards and Technology (NIST), part of the U.S. Department of Commerce. The reference material is designed for research purposes, specifically to evaluate methods for determining physicochemical and biophysical attributes of monoclonal antibodies, with potential uses including system suitability tests, method performance assessment, and analytical method comparison.
The RM consists of one cryovial containing 800 µL of 10 mg/mL IgG1κ monoclonal antibody in a specific buffer solution (12.5 mmol/L L-histidine, 12.5 mmol/L L-histidine HCl at pH 6.0). It is explicitly NOT intended for animal or human consumption, clinical testing, or therapeutic use. The material is not classified as a hazard under OSHA regulations, does not require a Safety Data Sheet, and is not regulated for transportation by DOT or IATA. Users are advised to use standard personal protective equipment when handling the reference material and to dispose of it in accordance with local, state, and federal regulations.
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Other files
| File | Type | Posted |
|---|---|---|
| Revision Statement of Work.pdf | ||
| Attch 1- Revised Statement of Work_KY 082625.docx | DOCX document | |
| 2 Questions and Answers .xlsx | XLSX spreadsheet | |
| Attch 1- Statement of Work_KY 082625.docx | DOCX document | |
| 8671 14HB-D-001.pdf | ||
| Attch 4- Past Performance Questionnaire.pdf | ||
| Attch 3- Experience Project Data Sheet.docx | DOCX document | |
| Attch 2- Provisions for Completion.docx | DOCX document | |
| Attch 1- Statement of Work.docx | DOCX document | |
| Final RFQ MAB VIALING 8.13.25.docx | DOCX document | |
| Attch 5- QAs.xls | XLS spreadsheet |
Show all 11
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Text version
RM 8671 Page 1 of 1
DATE: 14 September 2023
Product Identifier
RM Number: 8671 RM Name: NIST mAb, Humanized IgG1κ Monoclonal Antibody
Under the U.S. Department of Labor, Occupational Safety and Health Administration (OSHA) 29 CFR 1910.1200, this Reference Material (RM) is NOT classified as a physical hazard or a health hazard, a simple asphyxiant, combustible dust, pyrophoric gas, or hazard not otherwise classified. There are no hazard pictograms, hazard statements or signal word associated with it. Safety Data Sheet information is not required. This document may be used in conjunction with your hazard communication program.
Description: This RM is intended primarily for use in evaluating the performance of methods for determining physicochemical and biophysical attributes of monoclonal antibodies. It also provides a representative test molecule for development of novel technology for therapeutic protein characterization. This RM can be used for a variety of uses that may include system suitability tests, establishing method or instrument performance and variability, comparing changing analytical test methods, and assisting in method qualification. A unit of RM 8671 consists of one cryovial containing 800 µL of 10 mg/mL IgG1κ monoclonal antibody in 12.5 mmol/L L-histidine, 12.5 mmol/L L-histidine HCl (pH 6.0).
Additional Notes: RM 8671 IS INTENDED FOR RESEARCH USE. NOT INTENDED FOR ANIMAL OR HUMAN CONSUMPTION, CLINICAL TESTING, OR THERAPEUTIC USE. As a general rule, personal protective equipment should always be worn during any laboratory procedure. This includes, but is not limited to safety goggles, gloves, and a laboratory jacket.
Disposal: RM 8671 should be disposed of in accordance with local, state, and federal regulations.
Transport Information: This material is not regulated by the U.S. Department of Transportation (DOT) and/or International Air Transport Association (IATA).
Disclaimer: The NIST information in this document is specific to the NIST product and is believed to be correct, based upon our current knowledge. This document may not necessarily be all inclusive and should be used only as a guide. NIST does not guarantee the accuracy or completeness of this information. The only official source for specific values and uncertainties is the certificate or report.
Users of this RM should ensure that this document and the corresponding Report of Investigation in their possession are current. This can be accomplished by contacting the SRM Program: telephone (301) 975-2200;
e-mail srmmsds@nist.gov; or via the Internet at https://www.nist.gov/srm.
File details come from the government source that posted it. Updated .