• Online only
100GC® Mycoplasma gallisepticum (Illustration similar or symbolic)
Illustration similar or symbolic

100GC® Mycoplasma gallisepticum

100GC® Mycoplasma Standards are purified nucleic acid standards designed as reference material for product-specific validation of PCR-based mycoplasma testing methods.
- Compliant with EP 2.6.7 (12.2) and USP <77>
- Defined concentration of <100 GC/ml
- Suitable for product-specific validation and for use as EPC/EIC
- Optimized for PCR-based applications

Cat. No.: 104-3001

€390.00
Tax excluded excl. Shipping costs
This store cannot sell to USA, Canada and Mexico.
If you want your order to be delivered to these countries please visit our American store: https://minervabiolabs.us
Categories:

Related products

Do you have questions

Do you have questions...

... about using our products?
Contact Technical Support
... about ordering our products?
Get Ordering Help
... or about our company?
Send General Inquiry
Notification of Changes

Notification of Changes

Let us notify you about our product updates.

Register here

Resources

Manual.pdf
Compliance Information.pdf
SDS.pdf
Flyer.pdf
Poster.pdf
Validation Guide
100GC® Mycoplasma gallisepticum Validation Guide for 100GC® Mycoplasma gallisepticum

Please use this form to request a validation guide.

All fields are required. Please use your business contact data.

Please provide your first name. Please provide your last name. The e-mail seems to be missing or incorrect. Please provide your company/institution.
Send Validation Guide
close
cancel Unfortunately an error ocurred and the Validation Guide has not been sent.
Please, try again. If the problem persists please contact us at info@minerva-biolabs.com
Try again
close
check_circle Validation Guide has been sucesfully sent.
Newsletter:
close
close
CoA Search

Product Description

Validated mycoplasma testing is required for biopharmaceutical products, cell culture-derived products, and ATMPs according to EP 2.6.7, USP <77>, and JP 18 G3.

With the revision of EP 2.6.7, Edition 12.2, and the introduction of USP <77>, NAT-based mycoplasma testing is supported by the unit genome copies (GC). In addition to the established limit of ≤ 10 CFU/mL, a sensitivity requirement of < 100 GC/mL has been introduced for PCR-based mycoplasma detection.

100GC® Mycoplasma Standards are purified mycoplasma nucleic acid standards designed to meet these regulatory requirements. They are suitable for LOD determination, product-specific validation (“test for inhibitory substances” and “method suitability testing”), and use as external positive control (EPC)/extraction inhibition control (EIC) in NAT-based mycoplasma testing.

Manufactured in accordance with EP 2.6.7 (12.2), the standards support validated mycoplasma detection workflows according to EP 2.6.7, USP <77>, and JP 18 G3.

The exact GC value is provided in the Certificate of Analysis (CoA).

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

Application-Specific Relevance

Mycoplasma gallisepticum is a characteristic avian-associated mycoplasma species and is particularly linked to poultry- or egg-derived raw materials. The 100GC® Mycoplasma gallisepticum standard is therefore especially relevant for manufacturing processes with avian origin and supports matrix-specific assessment of potential contamination risks in corresponding production systems.

Specification

Product category 100GC® Mycoplasma Standards
Species Mycoplasma gallisepticum (Mycoplasmoides gallisepticum)
Sample type Purified mycoplasma nucleic acids (DNA/RNA-containing)
NCTC code 10115
ATCC code 19610
Application Mycoplasma detection
Application areas
  • Product-specific validation
  • Test for inhibitory substances (EP 2.6.7)
  • Method suitability test (USP <77>)
  • External positive control (EPC/EIC)
Contents
  • 3 vials each containing 100 GC (lyophilized)
  • 1 vial PCR-grade water
Detection method
  • PCR
  • real-time PCR (qPCR)
  • digital PCR (dPCR/ddPCR™)
Compliance EP 2.6.7 and USP <77>
Required equipment
& consumables
  • PCR thermal cycler
  • PCR reaction tubes
  • Centrifuge for 1.5 ml PCR tubes
  • Pipettes
  • Mycoplasma detection kit
Concentration <100 GC/ml (exact value provided in CoA)
Storage 2-8 °C
Shipping Ambient temperature
Shelf life See expiration date on package

More Available Species

Cat. No. 104-1001: Mycoplasma arginini
Cat. No. 104-2001: Mycoplasma orale
Cat. No. 104-4001: Mycoplasma pneumoniae
Cat. No. 104-5001: Mycoplasma synoviae
Cat. No. 104-6001: Mycoplasma fermentans
Cat. No. 104-7001: Mycoplasma hyorhinis
Cat. No. 104-8001: Acholeplasma laidlawii
Cat. No. 104-9001: Spiroplasma citri
Cat. No. 104-1101: Mycoplasma salivarium

FAQ for this product