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100CFU® Mycoplasma arginini (Illustration similar or symbolic)
Illustration similar or symbolic

100CFU® Mycoplasma arginini

100CFU® Mycoplasma Standards are inactivated, lyophilized mycoplasma particles suitable for method validation and for use as an External Positive Control in NAT-based mycoplasma testing.
- EP 2.6.7 (12.2), USP <77>, and JP 18 G3 compliant
- ≤100 CFU/ml, <10 GC:CFU
- Non-infectious, lyophilized

Cat. No.: 106-1001

€690.00
Tax excluded excl. Shipping costs
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Resources

Manual.pdf
Compliance Information.pdf
SDS.pdf
Flyer.pdf
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Product Description

Mycoplasma contamination represents one of the major risks in cell culture systems and biopharmaceutical manufacturing, including ATMPs. The European Pharmacopoeia (EP) 2.6.7, the United States Pharmacopeia (USP) <77>, and the Japanese Pharmacopoeia (JP) 18 G3 require validated test methods capable of reliably detecting both cultivable and non-cultivable mycoplasma.

100CFU® Mycoplasma Standards were specifically developed to meet these regulatory requirements and are particularly intended for use as an External Positive Control (EPC). Manufactured in accordance with EP 2.6.7 (edition 12.2), the standards are non-infectious and safe to handle. After reconstitution, defined quantities of the standard are spiked into the respective product or sample matrix to enable robust assessment of assay performance under routine conditions and to support Limit of Detection (LOD) determination.

Application-Specific Relevance

Mycoplasma arginini is closely associated with bovine contamination sources and is particularly considered in processes involving bovine-derived raw materials such as serum. The 100CFU® Mycoplasma arginini standard is therefore especially relevant for manufacturing settings using bovine materials and supports matrix-specific assessment of potential contamination risks.

Specification

Product category 100CFU® Mycoplasma Standards
Species Mycoplasma arginini
Sample type Inactivated mycoplasma particles (DNA/RNA-containing)
NCTC code 10129
ATCC code 23838
Application NAT-based mycoplasma testing
Application areas
  • Method validation
  • External positive control
  • Assay performance evaluation
  • QC release and routine testing
Regulatory compliance EP 2.6.7 (12.2), USP <77>, JP 18 G3
Contents
  • 3 vials ≤100 CFU (lyophilized)
  • 1 vial PCR-grade water
Detection method
  • PCR
  • real-time PCR (qPCR)
  • digital PCR (dPCR/ddPCR™)
Required equipment
& consumables
  • PCR reaction tubes
  • Centrifuge for 1.5 ml PCR reaction tubes
  • Pipettes
  • Mycoplasma detection kit
Concentration ≤100 CFU/ml
Storage 2-8 °C
Shipping Ambient temperature
Shelf life See package labeling

More Available Species

Cat. No. 106-2001: Mycoplasma orale
Cat. No. 106-3001: Mycoplasma gallisepticum
Cat. No. 106-4001: Mycoplasma pneumoniae
Cat. No. 106-5001: Mycoplasma synoviae
Cat. No. 106-6001: Mycoplasma fermentans
Cat. No. 106-7001: Mycoplasma hyorhinis
Cat. No. 106-8001: Acholeplasma laidlawii
Cat. No. 106-9001: Spiroplasma citri
Cat. No. 106-1101: Mycoplasma salivarium