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

100CFU® Mycoplasma arginini

100CFU® Mycoplasma Standards are inactivated, non-infectious, lyophilized mycoplasma particles designed for use as an external positive control (EPC/EIC) in PCR-based mycoplasma testing.
- Compliant with EP 2.6.7 (12.2), USP <77>, and JP 18 G3
- Defined concentration of ≤100 CFU/ml, GC:CFU ratio <10
- Recommended for use as EPC/EIC

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
Validation Guide
100CFU® Mycoplasma arginini Validation Guide for 100CFU® Mycoplasma arginini

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Product Description

100CFU® Mycoplasma Standards are non-infectious, inactivated mycoplasma reference standards for NAT-based mycoplasma testing of biopharmaceuticals, cell culture-derived products, and ATMPs.

They are designed for use as external positive control (EPC) according to EP 2.6.7 and as an extraction inhibition control (EIC) according to USP <77>, supporting a reliable control concept in routine mycoplasma testing.

Manufactured in accordance with EP 2.6.7 (12.2), the standards are non-infectious and safe to handle. After reconstitution, defined amounts of the standard are spiked into the relevant product or sample matrix to enable robust assessment of assay performance under routine conditions.

Not sure which mycoplasma standard to choose? Learn how to select the right reference material for validation and routine testing.

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 (Mycoplasmopsis arginini)
Sample type Inactivated mycoplasma particles (DNA/RNA-containing)
NCTC code 10129
ATCC code 23838
Application NAT-based mycoplasma testing
Application areas External positiv control (EPC) or Extraction inhibition control (EIC)
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