We provide
the Essential Value
We add value of your understanding of regulatory guidance on
Impurity
Extractables and Leachables
CCIT (Container closure Integrity testing)
Also, Saint-Gobain with Tubing and Bag as Single use system
We provide
the Essential Value
We add value of your understanding of regulatory guidance on
Impurity
Extractables and Leachables
CCIT (Container closure Integrity testing)
Also, Saint-Gobain with Tubing and Bag as Single use system
SWISS BASEL, E&L SCHOOL Welcome KOREA CUSTOMER
🌐 Quality by Design Inc. - Your Trusted Partner in E&L Studies 🌐
At Quality by Design Inc., we pride ourselves on being at the forefront of the Extractables and Leachables (E&L) study landscape. Our comprehensive services cover:
🔍 Consultation on the current E&L study approach
🔬 Critical assessment and evaluation
📜 Extractables & Leachables study and profiling
🧪 Identification & Toxicological evaluations
🛡️ Risk and Safety assessments
✅ Regulatory Registration support
Key Areas of Expertise:
"We proudly showcase our global regulatory expertise, with a track record of obtaining product approvals across:
Have an inquiry or need expert advice? 📩 Reach out to us at qbd@qbd.co.kr
For a more in-depth look at what we offer, visit our official website at www.qbd.co.kr
Let's navigate the complexities of E&L together! We look forward to partnering with you. 💼🌟
E&L and Pharmaceutical Regulatory Compliance AI
의약품 인허가 관련 질문하시고 간단한 답변 받으실 수 있습니다.
Special Case Compounds
Polycyclic Aromatic Hydrocarbons (PAHs) or Polynuclear Aromatics (PNAs), N-nitrosamines, and 2-mercaptobenzothiozole (2-MBT) are considered to be “special case” compounds (i.e., compounds with special safety and historical concerns), requiring special characterization studies using specific analytical techniques and methods (1–3,5). Thresholds for characterization of these compounds as extractables or leachables in OINDP are typically based on the limits of these specific analytical techniques and methods. Table 2 lists the PNAs and N-nitrosamines that, along with 2-MBT, are typically investigated as extractables and leachables in OINDP.
PNAs have been associated with carbon black filler used in many types of elastomer. Analysis of PNAs, either as elastomer extractables or as drug product leachables, usually involves quantitative extraction followed by highly specific and sensitive analysis of resulting extracts. GC/MS with selected-ion-monitoring has been reported for analysis of target PNAs as leachables in MDI drug products, for example (6). N-Nitrosamines are reaction products between specific organic precursor molecules, secondary amines (R2NH), and a “nitrosating agent”. In the compounding of rubber, secondary amines are likely formed from certain vulcanization accelerators such as thiurams and dithiocarbamates. Potential nitrosating agents include NO+, N2O3, N2O4, etc., certain of which can be formed from commonly used chemicals such as sodium nitrite (NaNO2), which has many industrial uses. Analysis of N-nitrosamines in rubber as potential leachables involves quantitative extraction followed by analysis of extracts with gas chromatography/thermal energy analysis detection (GC/TEA) (8). Analysis of N-nitrosamines as leachables in MDI drug products using GC/TEA has been reported (7). The 2-MBT is a vulcanization accelerator, which is used in certain sulfur-cured elastomers, and can be analyzed by extraction followed by LC/MS (5).