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Looking for reference standards & impurity standards for APIs? Find a leading CMO, CDMO offering primary & secondary standards on PharmaCompass.

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API & Drug Product Development
API Development
Impurity / Reference Standard

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.

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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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01 1Advinus Therapeutics Ltd

02 1Almelo

03 2Anacipher

04 1Aozeal Certified Standards

05 1Aragen Life Sciences

06 1Bellen Chemistry

07 1Bioindustria L.I.M. Spa

08 1ChemCon GmbH

09 1Chromcore Lifesciences

10 1Cleanchem Laboratories

11 3Clearsynth Labs Limited

12 2Dalton Pharma Services

13 1Diverchim S.A.

14 1Eurofins CDMO

15 1Evotec

16 1GRAM Laboratory Inc

17 1Kekule Pharma

18 1KriSan Biotech

19 3Maithili Life Sciences

20 1Prague Scientific

21 1Priyans Drugs

22 1Recipharm AB

23 1SVAK Life Sciences

24 1Sai Life Sciences Limited

25 1Solara Active Pharma Sciences

26 1TopChem Pharmaceuticals

27 1UQUIFA

28 1USP

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34 All

01 2Canada

02 1China

03 1Czech Republic

04 2France

05 2Germany

06 17India

07 1Ireland

08 1Italy

09 1Singapore

10 1Spain

11 1Sweden

12 1Taiwan

13 3U.S.A

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01

Maithili Life Sciences

SYNTHESIS & ISOLATION OF IMPURITIES

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Maithili Life Sciences

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Pharma Service : API & Drug Product Development

SYNTHESIS & ISOLATION OF IMPURITIES

Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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02

Advinus Therapeutics Ltd

METABOLITE AND IMPURITY SYNTHESIS

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Advinus Therapeutics Ltd

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Pharma Service : API & Drug Product Development

METABOLITE AND IMPURITY SYNTHESIS

Advinus offers a full range of chemistry services spanning miligram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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03

USP

REFERENCE STANDARDS FOR APIs

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USP

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Pharma Service : API & Drug Product Development

REFERENCE STANDARDS FOR APIs

USP offers primary standards to ensure quality in pharmaceutical development & manufacturing. USP reference standards are rigorously tested & evaluated by multiple independent laboratories including USP, commercial, regulatory & academic labs.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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04

Bioindustria L.I.M. Spa

DEGRADATION IMPURITIES

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Bioindustria L.I.M. Spa

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Pharma Service : API & Drug Product Development

DEGRADATION IMPURITIES

Bioindustria L.I.M's R&D laboratories are in charge of synthesizing process and degradation impurities for analytical purposes and to support customers in developing generics.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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05

UQUIFA

IMPURITY PROFILE CHARACTERIZATION

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UQUIFA

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Pharma Service : API & Drug Product Development

IMPURITY PROFILE CHARACTERIZATION

Uquifa is a leading company for APIs and advanced intermediates offering capabilities including impurity profile characterization, stability studies, process validation and analytical method development services.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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06

Solara Active Pharma Sciences

IMPURITY / REFERENCE STANDARD

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Solara Active Pharma Sciences

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Pharma Service : API & Drug Product Development

IMPURITY / REFERENCE STANDARD

Solara has a synthetic development team dedicated to impurity synthesis, with more than 800 compounds available. Their analytical services include impurity marker & reference standard preparation, qualification, management & distribution.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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07

Maithili Life Sciences

IMPURITY, DEGRADANT OR METABOLITE ISOLAT...

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Maithili Life Sciences

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Pharma Service : API & Drug Product Development

IMPURITY, DEGRADANT OR METABOLITE ISOLAT...

Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
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08

Priyans Drugs

SYNTHESIS OF IMPURITIES & STANDARDS

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Priyans Drugs

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Pharma Service : API & Drug Product Development

SYNTHESIS OF IMPURITIES & STANDARDS

Priyans Drugs headquartered in Singapore, is a professionally managed company supporting the pharmaceuticals business globally.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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09

Aozeal Certified Standards

SYNTHESIS OF IMPURITIES & REFERENCE STAN...

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Aozeal Certified Standards

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Pharma Service : API & Drug Product Development

SYNTHESIS OF IMPURITIES & REFERENCE STAN...

Aozeal Certified Standards (AOCS), Inc. is a high-tech biopharmaceutical company specialized in the custom synthesis & supply of API impurities & other pharmaceutical reference standards as per a customers’ desired purity, characterization & quantity.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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10

Clearsynth Labs Limited

RELATED COMPOUNDS & POTENTIAL IMPURITIES

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Clearsynth Labs Limited

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Pharma Service : API & Drug Product Development

RELATED COMPOUNDS & POTENTIAL IMPURITIES

Clearsynth services are applied at all stages of development. Clearsynth considers all issues related to compounds and potential impurities.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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11

KriSan Biotech

IMPURITY REFERENCE STANDARDS

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KriSan Biotech

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Pharma Service : API & Drug Product Development

IMPURITY REFERENCE STANDARDS

KriSan Biotech offers research and process development services to prepare impurity reference standards, active pharmaceutical ingredients (APIs) and intermediates.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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12

Eurofins CDMO

IMPURITY SYNTHESIS

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Eurofins CDMO

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Pharma Service : API & Drug Product Development

IMPURITY SYNTHESIS

Eurofins CDMO identifies, isolates & synthesizes process related impurities to support process development, analytical control & regulatory requirements. They offer services for the whole drug development process & manage impurities synthesis & control.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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13

Kekule Pharma

IMPURITY SYNTHESIS

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Kekule Pharma

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Pharma Service : API & Drug Product Development

IMPURITY SYNTHESIS

Kekule Pharma offers various services including impurity synthesis, drug substance contract manufacturing, etc.They specialize in producing products through novel processes taking full advantage of their core competencies, equipment & facilities.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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14

Recipharm AB

REFERENCE STANDARDS

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Recipharm AB

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Pharma Service : API & Drug Product Development

REFERENCE STANDARDS

Recipharm's specialities include preparation of reference standards & internal standards with stable isotopes, synthesis of complex heterocycles, sugars, steroids, ADC linkers, phosphates, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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15

GRAM Laboratory Inc

API REFERENCE STANDARD QUALIFICATION

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GRAM Laboratory Inc

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Pharma Service : API & Drug Product Development

API REFERENCE STANDARD QUALIFICATION

GRAM Laboratories provides services geared towards qualification of an active pharmaceutical ingredient, through monograph testing, compendial and vendor method verification, qualification of impurity profile and reference standard qualification.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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16

Maithili Life Sciences

SYNTHESIS OF GMP IMPURITIES

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Maithili Life Sciences

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Pharma Service : API & Drug Product Development

SYNTHESIS OF GMP IMPURITIES

Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

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17

ChemCon GmbH

SYNTHESIS OF REFERENCE STANDARDS

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ChemCon GmbH

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SYNTHESIS OF REFERENCE STANDARDS

ChemCon can synthesize and qualify reference standards as per client's needs. It combines the expertise and facilities of an analytical service provider with those of an experienced custom synthesis development and manufacturing organization (CDMO).

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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18

Anacipher

SYNTHESIS OF KNOWN / UNKNOWN IMPURITIES

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Anacipher

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Pharma Service : API & Drug Product Development

SYNTHESIS OF KNOWN / UNKNOWN IMPURITIES

With the help of deep organic chemistry knowledge along with state-of-the-art synthesis infrastructure, Anacipher offers synthesis services for known / unknown impurities.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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19

Anacipher

REFERENCE STANDARDS AND IMPURITIES

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Anacipher

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Pharma Service : API & Drug Product Development

REFERENCE STANDARDS AND IMPURITIES

Reference standards / working standards of impurities & products can be qualified & characterized with a complete report for regulatory submission. Anacipher helps in in-house impurity standard generation by means of degradation & isolation or synthesis.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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20

Clearsynth Labs Limited

REFERENCE STANDARDS

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Clearsynth Labs Limited

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Pharma Service : API & Drug Product Development

REFERENCE STANDARDS

Clearsynth's team of experienced scientists has expertise in the custom synthesis of a range of small molecules like APIs, chemical intermediates, drug metabolites, drug analogs, analytical standards, reference standards, pharmaceutical impurities, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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21

Clearsynth Labs Limited

PHARMACEUTICAL IMPURITIES

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Clearsynth Labs Limited

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Pharma Service : API & Drug Product Development

PHARMACEUTICAL IMPURITIES

Clearsynth's team of experienced scientists has expertise in the custom synthesis of a range of small molecules like APIs, chemical intermediates, drug metabolites, drug analogs, analytical standards, reference standards, pharmaceutical impurities, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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22

Prague Scientific

NITROSAMINE IMPURITY SYNTHESIS & ANALYSI...

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Prague Scientific

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Pharma Service : API & Drug Product Development

NITROSAMINE IMPURITY SYNTHESIS & ANALYSI...

Prague Scientific offers synthesis and analytical characterization of nitrosamine standards with confirmatory nitrosamine testing on the ppb/ppm level (analytical method development and validation).

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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23

Sai Life Sciences Limited

SYNTHESIS OF REFERENCE COMPOUNDS

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Sai Life Sciences Limited

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Pharma Service : API & Drug Product Development

SYNTHESIS OF REFERENCE COMPOUNDS

The key services offered by Sai Life Sciences include synthesis of reference compounds, lead generation and optimization, preparation of building blocks/key intermediates, metabolites, and impurity markers, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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24

Cleanchem Laboratories

DEVELOPMENT OF IMPURITY REFERENCE STANDA...

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Cleanchem Laboratories

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Pharma Service : API & Drug Product Development

DEVELOPMENT OF IMPURITY REFERENCE STANDA...

Cleanchem Laboratories is a contract research and manufacturing service provider that delivers impurity synthesis services. It also offers custom development of impurity reference standards, specialty chemicals, intermediates, metabolites, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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25

SVAK Life Sciences

IMPURITY REFERENCE STANDARD (IRS)

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SVAK Life Sciences

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Pharma Service : API & Drug Product Development

IMPURITY REFERENCE STANDARD (IRS)

SVAK handles process development projects, cost reduction projects and impurity standards worldwide for a client base that includes pharmaceuticals, manufacturers of specialty chemicals, as well as universities and various other research institutions.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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26

TopChem Pharmaceuticals

IMPURITIES, METABOLITES & RELATED MATERI...

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TopChem Pharmaceuticals

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IMPURITIES, METABOLITES & RELATED MATERI...

Topchem can supply impurity reference standards (IRS), metabolites and related research materials. Using their supply chain network they generally source advanced intermediates to facilitate rapid and cost effective supply of these materials.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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27

Bellen Chemistry

IMPURITY & REFERENCE STANDARD SYNTHESIS

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Bellen Chemistry

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IMPURITY & REFERENCE STANDARD SYNTHESIS

Bellen's development service capabilities include synthesis of reference compounds, impurity markers, preparation of key intermediates, building blocks, design and synthesis of focused libraries, lead optimization and preclinical candidate selection, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

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28

Almelo

IMPURITY SYNTHESIS

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Almelo

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Pharma Service : API & Drug Product Development

IMPURITY SYNTHESIS

The Almelo Research Center (ARC) is a fully established facility for Almelo's in-house and custom product R&D services.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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29

Evotec

IMPURITY / REFERENCE STANDARD

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Evotec

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Pharma Service : API & Drug Product Development

IMPURITY / REFERENCE STANDARD

Evotec supports the key steps of the development of its partner’s APIs in route scouting & identification of a new route, custom synthesis, analytical method development & validation, synthesis of reference standards & impurities, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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30

Aragen Life Sciences

IMPURITY IDENTIFICATION, CHARACTERISATIO...

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Aragen Life Sciences

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Pharma Service : API & Drug Product Development

IMPURITY IDENTIFICATION, CHARACTERISATIO...

GVK BIO offers an extensive Process R&D support, designed to address the issues involving both scientific and communication challenges. We are cognizant of the need for customisation as per client’s need.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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31

Chromcore Lifesciences

IMPURITIES TESTING

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Chromcore Lifesciences

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Pharma Service : API & Drug Product Development

IMPURITIES TESTING

Chromcore provides various analytical testing services such as impurity testing, dose content uniformity for inhalation products such as dry-powder inhaler (DPI) & metered-dose inhaler (MDI), water or moisture content analysis, drug content (assay), etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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32

Diverchim S.A.

IMPURITY REFERENCE STANDARDS (IRS) SUPPL...

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Diverchim S.A.

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Pharma Service : API & Drug Product Development

IMPURITY REFERENCE STANDARDS (IRS) SUPPL...

DIVERCHIM can supply its customer impurity reference standards, in response to health agencies’ requirements for impurity definition and characterization.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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33

Dalton Pharma Services

IMPURITY SCREENING

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Dalton Pharma Services

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Pharma Service : API & Drug Product Development

IMPURITY SCREENING

Identification of Unknown impurities of >0.05% abundance using internally developed or client supplied method.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
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34

Dalton Pharma Services

IMPURITY REFERENCE STANDARDS

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Dalton Pharma Services

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Pharma Service : API & Drug Product Development

IMPURITY REFERENCE STANDARDS

Identified compounds can be ultra-purified for use as reference standards for QC analysis and stability impurity monitoring studies.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

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