LVV

USP Analytical Reference Materials

• Genomic DNA for Lentiviral Integration Copy Number (Digital PCR) (5 ug)
• Genomic DNA for Lentiviral Integration Copy Number (qPCR) (5 ug)

USP Monographs

• Octoxynol 9
  • Reference Standard: USP Nonoxynol 9 RS
  • Reference Standard: USP Octoxynol 9 RS
• L-Alanyl-L-glutamine
  • Reference Standard: USP Glutamine RS
  • Reference Standard: USP l-Alanine RS
  • Reference Standard: USP l-Alanyl-l-alanine RS
  • Reference Standard: USP l-Alanyl-l-glutamine RS
• Glutamine
  • Reference Standard: USP Glutamine RS
• Poloxamer
  • Reference Standard: USP Poloxamer Liquid RS
  • Reference Standard: USP Poloxamer Solid RS
• Dextrose
  • Reference Standard: USP Dextrose RS
  • Reference Standard: USP Fructose RS
  • Reference Standard: USP Maltose Monohydrate RS
  • Reference Standard: USP Maltotriose RS
• Dextrose excipient
  • Reference Standard: USP Dextrose RS
  • Reference Standard: USP Fructose RS
  • Reference Standard: USP Maltose Monohydrate RS
  • Reference Standard: USP Maltotriose RS
• Magnesium Chloride
  • Reference Standard: USP Magnesium Chloride RS
• Dimethyl Sulfoxide
  • Reference Standard: USP Dimethyl Sulfoxide RS

USP-NF Chapters

• 〈61〉 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
• 〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
• 〈63〉 Mycoplasma Tests
• 〈71〉 Sterility Tests
• 〈85〉 Bacterial Endotoxins Test
  • Reference Standard: USP Endotoxin RS
• 〈87〉 Biological Reactivity Tests, In Vitro
  • Reference Standard: USP High-Density Polyethylene RS
• 〈88〉 Biological Reactivity Tests, In Vivo
  • Reference Standard: USP High-Density Polyethylene RS
• 〈89〉 Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
  • Reference Standard: USP Trypsin Recombinant Porcine RS
• 〈507〉 Protein Determination Procedures
  • Reference Standard: USP BSA for Protein Quantitation RS
• 〈509〉 Residual DNA Testing
  • Reference Standard: USP CHO Genomic DNA RS
  • Reference Standard: USP E. coli Genomic DNA RS
  • Analytical Reference Material: Quantitative HEK-293 Genomic DNA
• 〈785〉 Osmolality and Osmolarity
• 〈788〉 Particulate Matter in Injections
  • Reference Standard: USP Particle Count RS
• 〈789〉 Particulate Matter in Ophthalmic Solutions
• 〈790〉 Visible Particulates in Injections
• 〈791〉 pH
• 〈1027〉 Flow Cytometry
• 〈1040〉 Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies
• 〈1042〉 Cell Banking Practices for Recombinant Biologics
• 〈1043〉 Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
• 〈1044〉 Cryopreservation of Cells
• 〈1047〉 Gene Therapy Products
• 〈1050〉 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
• 〈1071〉 Rapid Sterility Testing of Short Life Products A Risk Based Approach
• 〈1085〉 Guidelines on the Endotoxins Test
• 〈1103〉 Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
• 〈1104〉 Immunological Test Methods—Immunoblot Analysis
• 〈1125〉 Nucleic Acid-Based Techniques—General
• 〈1126〉 Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing
• 〈1127〉 Nucleic Acid-Based Techniques—Amplification
• 〈1128〉 Nucleic Acid-Based Techniques—Microarray
• 〈1130〉 Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
• 〈1132〉 Residual Host Cell Protein Measurement in Biopharmaceuticals
• 〈1430.3〉 Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering
• 〈1776〉 Image Analysis of Pharmaceutical Systems
• 〈1787〉 Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
• 〈1788.3〉 Flow Imaging Method for the Determination of Subvisible Particulate Matter
• 〈1790〉 Visual Inspection of Injections