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45 Companies with Results for impurities 1 - 10 of 45

Cygnus Technologies Inc.

4332 Southport Supply Rd SE Southport, NC 28461 Tel: 910-454-9442

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... Place - Boston, MA Find solutions to comprehensive bioprocess impurity analysis @ booth # 506 Multi-Method Analysis of your Host Cell Protein Impurities © 2017 Cygnus Technologies HOME | PRODUCTS | | SITEMAP | TERMS & CONDITIONS ...

Alcami

2320 Scientific Park Drive Wilmington, NC 28405 Tel: 800-575-4224

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Alcami CONNECT | Regulatory Compliance

... Continue Reading 2 Comments Topics: Regulatory Compliance Elemental Impurities – Highlights of the Coming Regulation by Walter Holberg , ... prior to the Q3D Guidance, regulation of elemental impurities fell under Guideline Q3A for inorganic impurities. Existing ...

Elemental Impurities

... you stay in compliance with the upcoming elemental impurities regulatory change ... elemental impurities ARE YOU READY FOR THE REPLACEMENT OF USP <231> HEAVY METALS? Alcami Wants You to Stay in ...

Alcami CONNECT

... Wilmington Announce Academic Partnership ON-DEMAND WEBINAR: Elemental Impurities - A Deep Dive into Potential Contamination Sources Video: ... the Light to Photostability in Three Parts Elemental Impurities – Highlights of the Coming Regulation ON-DEMAND WEBINAR: ...

Alcami CONNECT | Webinars

... 1 Comment Topics: Webinars ON-DEMAND WEBINAR: Elemental Impurities - A Deep Dive into Potential Contamination Sources by ... An often overlooked scenario when testing for elemental impurities is the possible contamination from everyday pharmaceutical machinery. ...

Alcami CONNECT

... and for the concomitant determination of Assay and impurities. However, microbiological assays provide a true measure of ... Continue Reading 0 Comments Topics: Company News Elemental Impurities: The Risk-Based Approach by Catherine Hanley , on ...

Framework to Biologics – A Three Part Series

... technologies. Biologics produced in cell culture contain unique impurities, including host cell proteins and host cell DNA. ... drug substance. Residual host DNA is a cellular impurity that arises from the use of host cells ...

Alcami CONNECT

... Continue Reading 0 Comments Topics: Thought Leadership Elemental Impurities – Highlights of the Coming Regulation by Walter Holberg , ... prior to the Q3D Guidance, regulation of elemental impurities fell under Guideline Q3A for inorganic impurities. Existing ...

Alcami CONNECT

ON-DEMAND WEBINAR: Elemental Impurities - Everything You Need to Know by Catherine Hanley , on Mar 30, 2017 10:00:00 AM The introduction of new guidelines relating to elemental impurities in pharmaceuticals from the International Conference on Harmonization ( ...

Biopharmaceutical Services

... Structural Characterization and Confirmation Physicochemical Properties Process-related Impurities Product-related Impurities Binding Ready to Get Started? ...

Alcami CONNECT | Alcami Voices

... a technique used for the determination of elemental impurities conformance to guideline ICH Q3D. HPLC-QTOF is ... with NMR, used for elucidation of structure of impurities. The thing I like the most about my ...

Alcami CONNECT | Bryan Troxell, Ph.D.

... technologies. Biologics produced in cell culture contain unique impurities, including host cell proteins and host cell DNA. ...

Vendor Terms and Conditions

... a part of a mixture or mixtures, including impurities, were not manufactured, processed or distributed in commerce ...

Alcami CONNECT

... CDMOs. Continue Reading 0 Comments Topics: Events Elemental Impurities: Updated Regulatory Requirements by Catherine Hanley , on Jan ...

Identifying and Reducing Risks within the Pharmaceutical Supply Chain

... resulted from quality issues with raw materials, including impurities, microbial contamination, and chemical instability. Clinical Holds Investigational ...

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... Continue Reading 2 Comments Topics: Regulatory Compliance Elemental Impurities – Highlights of the Coming Regulation by Walter Holberg , ... prior to the Q3D Guidance, regulation of elemental impurities fell under Guideline Q3A for inorganic impurities. Existing ...

Haemtech Biopharma Services

57 River Rd. Unit 1021 Essex Junction, VT 05452 Tel: 802-878-1777

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... addition, a myriad of testing for identity and impurities is also required for the release of an ... generation assay (TGA) Quantitative Test for Process-Related Impurities: Factor XIa and “Factor XIa-like” activity Factor ...

Sannova Analytical Inc.

155 Pierce Street Somerset, NJ 08873 Tel: 7325600066

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2014 *** FDA compliant Bioanalytical Contract Research Organization (CRO) Sannova Analytical Inc, Hanumantha Marepalli Kollu ...

Captisol, a Ligand technology

3911 Sorrento Valley Blvd, Suite 11 Suite 110 San Diego, CA 92121 Tel: 8585507895

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Order Now :: Captisol

... gram 0.5g $50 $0 RM-967-C50 Impurity- 4-Hydroxybutane-1-Sulfonic Acid 0.5 gram 0.5g $1,000 $0 RM-967-C10 Impurity- 4-Hydroxybutane-1-Sulfonic Acid 0.1 gram ...

Technology :: Captisol

... manufacturing process consistently practiced and improved to control impurities. The selection of Captisol and its desirable safety ...

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... gram 0.5g $50 $0 RM-967-C50 Impurity- 4-Hydroxybutane-1-Sulfonic Acid 0.5 gram 0.5g $1,000 $0 RM-967-C10 Impurity- 4-Hydroxybutane-1-Sulfonic Acid 0.1 gram ...

Simulations Plus

42505 10th Street West Lancaster, CA 93534 Tel: +1 661 723-7723

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Resource Center - Simulations Plus

... properties on the retention of pramipexole and its impurities Journal Articles Evaluation and comparison of benchmark QSAR ... compatible with topical application Journal Articles Identification of impurities in macrolides by liquid chromatography–mass spectrometric detection ...

Resource Center - Simulations Plus

... implication in toxicity assessment Journal Articles Identification of impurities in macrolides by liquid chromatography–mass spectrometric detection and prediction of retention times of impurities by constructing quantitative structure–retention relationship (QSRR) Journal ...

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... properties on the retention of pramipexole and its impurities Journal Articles Evaluation and comparison of benchmark QSAR ... compatible with topical application Journal Articles Identification of impurities in macrolides by liquid chromatography–mass spectrometric detection ...

Avomeen Analytical Services

4840 Venture Drive Ann Arbor, MI 48108 Tel: 800-930-5450

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CDER/ICH and FDA Method Development & Validation | Avomeen

... Validation • Comparative Studies • Gap Analysis & Remedial Validation • Process Impurity • Vendor Qualification • Extractables & Leachables • Chromatographic & Chiral Purity • USP ...

GMP Pharmaceutical Testing & Development‎ Lab | Avomeen

... Material & Compendial Testing, ICH Stability, CTM, Characterization, Q1Q2, Impurity ID, Monographs, E&L Studies. ... supplies, to the identification and quantitation of complex impurities and degradation products, our full-service laboratory has ...

FDA Release Testing | cGMP Testing Services | Avomeen

... of the formulation’s identity, potency and purity, impurities, uniformity, identity, presentation attributes, and sterility. What Products ...

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... Validation • Comparative Studies • Gap Analysis & Remedial Validation • Process Impurity • Vendor Qualification • Extractables & Leachables • Chromatographic & Chiral Purity • USP ...

Pfanstiehl, Inc.

1219 Glen Rock Avenue Waukegan, IL 60085 Tel: 847-623-0370

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Pfanstiehl - Galactose (NAD)

... Production • Increased Target Protein Production • Clean & Consistent Media Impurity Profile Pfanstiehl Brand Galactose is available as USP/ ...

Pfanstiehl - Profiling Metal Content

... to correlate application data with these and other impurity profiles, and to map their impacts on formulation ...

Pfanstiehl - Mannose

... Quality • Minimized Need to Troubleshoot Variants • Clean Media Impurity Profile Pfanstiehl Brand Mannose is available as USP- ...

Pfanstiehl - Resource Center

... for multi-compendial release testing, total and elemental impurities (down to low ppb levels), endotoxins, glucans, and ...

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... Production • Increased Target Protein Production • Clean & Consistent Media Impurity Profile Pfanstiehl Brand Galactose is available as USP/ ...

CoreRx, Inc.

14205 Myerlake Circle Clearwater, FL 33760 Tel: 727-259-6950

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... multi-point, and 2-stage dissolution methods Organic impurities methods using gas chromatography (GC) Cleaning methods for ...

CMC Pharmaceuticals, Inc.

7100 Euclid Avenue Suite 152 Cleveland, OH 44103 Tel: 216-600-9430

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... detector provides a valuable tool for method development, impurity & degradant identification, and a variety of trouble shooting ...

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