FOR IMMEDIATE RELEASE: PERMANENT CLOSURE OF CIAL: See below, letter from our President, Ron Sutton.
Compounder's International Analytical Laboratory
制药业
Castle Rock,CO 98 位关注者
The Gold Standard in Quality Testing
关于我们
CIAL specializes in providing highly affordable, personalized, accurate, and rapid pharmaceutical testing. We understand your need for crucial information to be assured your patients/clients are receiving the quality medications you and the physician intend. Because we appreciate your trust and envision our service as an extension of your pharmacy staff, we are personalized and confidential. Your success is our primary goal. We are always willing to discuss problems privately and to assist you in discovering solutions. If we do spot a problem we won’t merely send a report, but contact you directly to discuss the matter, offer suggestions, and work with you to achieve resolution.
- 网站
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https://www.compounderslab.com/
Compounder's International Analytical Laboratory的外部链接
- 所属行业
- 制药业
- 规模
- 11-50 人
- 总部
- Castle Rock,CO
- 类型
- 私人持股
- 创立
- 2005
- 领域
- Compendial Testing、Stability Indicating Assay、Dissolution <711>、Residual Solvents <467>、Sterility <71>、Potency <621>、Method Validation <1225>、UHPLC、Gas Chromatography、Endotoxin <85>、Microscopic Enumeration <61>、Microbial Examination <60>、USP、Rapid Sterility <71>和Method Suitability
地点
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主要
US,CO,Castle Rock,80109
Compounder's International Analytical Laboratory员工
动态
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Check out the CIAL booth at the A4M Longevity Conference in Vegas .. Say hi to our President and Vice President, Ronald and Nancy! #a4m #longevity #vegas #compounding #lab
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Compounder's International Analytical Laboratory转发了
FDA has published emergency guidance that empowers pharmacies to help address the nationwide IV solutions shortage. This move is similar to FDA’s temporary guidance during the COVID public health emergency that allowed 503A pharmacies, within tight guardrails, to prepare 13 essential COVID drugs in shortage for hospitals in the gap period before 503Bs could ramp up production. The quality compliance standards and production capacity needed to produce sterile IV fluids makes large-scale production of IV fluids practically prohibitive for most 503A pharmacies. APC leaders met with FDA last week in advance of them issuing this emergency guidance to brief them on what would be needed for compounders to help fill gaps and meet local needs. And that’s where we think some sterile compounding pharmacies may be able to help — meeting the needs of smaller, local hospitals in a limited but important way. Read them here: https://lnkd.in/ghXkp2Eq
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APC CEO Scott Brunner does a great job of articulating the Tirzepatide "shortage" debate. Thank you, Scott for your advocacy for compounders!
Okay, my first live TV interview. It's with Scripps News Service about FDA's abrupt decision to remove tirzepatide injection from the shortage list and what OFA's lawsuit (and the court's subsequent remand to FDA) might mean for patients. (Glad I had the foresight to keep an extra dress shirt and jacket at the office. I was in a hoodie when they called.) #compounding #pharmacycompounding #compoundedGLP1s Alliance for Pharmacy Compounding
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Exciting news from CIAL .. rapid sterility testing is available NOW!
Which lab now offers Rapid Sterility testing? CIAL does! ? Results in half the time - Utilizing the Celsis AMPiScreen? Assay (amplified ATP bioluminescence) ? Growth based, non-destructive, sterility testing - provides more confidence in your results ? Compatible with Filterable formulations - such as aqueous / oil injectables ? Validated alternative to <71> - compliant with <1223> and non-inferior to <71>
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Which lab now offers Rapid Sterility testing? CIAL does! ? Results in half the time - Utilizing the Celsis AMPiScreen? Assay (amplified ATP bioluminescence) ? Growth based, non-destructive, sterility testing - provides more confidence in your results ? Compatible with Filterable formulations - such as aqueous / oil injectables ? Validated alternative to <71> - compliant with <1223> and non-inferior to <71>
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CIAL has become "The Gold Standard" in Peptide testing for Compounders! What better way to counter media attacks than to support your compounded products with real test data? (After all, counterfeits don’t test what they make) ??Nothing beats an actual Certificate of Analysis (CoA) from an independent lab, like CIAL. ? Testing demonstrates your (GLP-1 peptides) formulations are safe, effective, and legitimate. ??Whether it is for your Semaglutide, Tirzepatide, or anything else, patients and regulators can be reassured when they know these medications have been verified with quality testing. Get the facts on GLP-1 Testing! 800-788-9922 | https://lnkd.in/gcw7SbSx
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CIAL has become "The Gold Standard" in Potency testing for Compounders! We use only state-of-the-art instrumentation, maintaining and calibrating our instrumentation to the highest industry standards. Here are some examples: UHPLC – Ultra High-Performance Liquid Chromatography allows for the best resolution of APIs, including GLP-1 peptides. LC-MS – Mass Spectroscopy (Triple Quad) provides the highest sensitivity for complex formulations such as vitamin blends. GC – Gas Chromatography can detect low levels of Glycerin, DEG / EG, and Residual Solvents, and is often used in compendial analysis. ICP-OES – Inductively Coupled Plasma – Optical Emission Spectroscopy can detect low levels of heavy metals and nutritional metals used in compounding. Our analysts are thoroughly trained and specialize in compounded formulations. We have a full-time, Validation Team dedicated to method development and validation of stability indicating assay (SIA) methods, per USP <795> and <797>. With nearly 20 years of expertise, our team is dedicated exclusively to serving compounders. What can CIAL test for you? 800-788-9922 | https://lnkd.in/gbbkcVFf
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