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제품 설명

100CFU® Spiroplasma citri

제품 번호

106-9001

제품 설명

• 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

  Spiroplasma citri belongs to the genus Spiroplasma and is phylogenetically distinct from classical mycoplasma species. It is particularly relevant for manufacturing processes involving insect or plant cell lines. The 100CFU® Spiroplasma citri standard supports matrix-specific assessment of potential contamination risks in non-mammalian expression systems.

  Specification

  Product category	100CFU® Mycoplasma Standards
  Species	Spiroplasma citri
  Sample type	Inactivated mycoplasma particles (DNA/RNA-containing)
  NCTC code	10164
  ATCC code	27556
  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. 106-1001: Mycoplasma arginini
  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. 106-1101: Mycoplasma salivarium

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