Compounder's International Analytical Laboratory的封面图片
Compounder's International Analytical Laboratory

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
https://www.compounderslab.com/
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

Compounder's International Analytical Laboratory员工

动态

  • 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

    • 该图片无替代文字
  • APC CEO Scott Brunner does a great job of articulating the Tirzepatide "shortage" debate. Thank you, Scott for your advocacy for compounders!

  • 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>

    • 该图片无替代文字
  • 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>

    • 该图片无替代文字
  • 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

    • 该图片无替代文字
  • 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

    • 该图片无替代文字

相似主页

查看职位