Pharma
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An Ausgangsstoffe für Arzneimittel- und Medizinprodukte werden hohe Qualitäts- und Sicherheitsanforderungen gestellt. Hedinger handelt, lagert, verpackt, analysiert und zertifiziert deshalb Ausgangsstoffe unter Einhaltung internationaler GMP-/GTDP-Anforderungen. Rückverfolgbarkeit, Transparenz der Supply Chain und Dokumentation sind hierbei essentielle Kriterien, die wir stringent einhalten.
Unsere GMP/GDP Compliance wurde auch im Rahmen behördlicher Inspektionen und unserer EXCiPACTTM Auditierung offiziell zertifiziert.
Hedinger besitzt eine Herstellungserlaubnis nach § 13 AMG. Im Rahmen dieser Erlaubnis unterzieht unsere Qualitätskontrolle jede einzelne Charge unserer pharmazeutischen Ausgangsstoffe einer Vollanalyse, führt Einzelprüfungen durch, die nach internationalen Arzneibüchern wie Ph. Eur., USP und JP gefordert sind und erstellt Analysenzertifikate nach WHO-GMP 17.17 und DIN EN 10204.
So sorgt die Qualitätskontrolle für lückenlose Dokumentationen und trägt dazu bei, dass Daten und Know-how reibungslos und vollständig ausgetauscht werden können. Praktisch einzigartig ist das Ergebnis: Jeder Ausgangsstoff-Lieferung von Hedinger ist ein Zertifikat mit der Chargennummer und allen Analysendaten beigefügt, die viele globale Pharmahersteller sogar in die Dokumentation ihrer Wareneingangskontrolle übernehmen.
Hier finden Sie weitergehende Informationen über unser Hedinger GMP/GDP System.
Produktliste, alphabetisch
- Acetic Acid 80% API grade
(produced with Purified Water Ph. Eur./USP)
Hedinger Purified Water Ph. Eur./USP - Acetic Acid customised aqueous solutions
(produced with Purified Water Ph. Eur./USP)Hedinger Purified Water Ph. Eur./USP - Acetic Acid, Glacial (99.9%) Ph. Eur. / USP / JP
- Acetic Acid Glacial (99.9%) Ph. Eur./USP/JP parenteral grade
Parenteral grade - Aceton Ph. Eur. / USP-NF / JPE
INEOS Acetone SQ - Aqueous solutions
(formulated with Highly Purified Water Ph. Eur./Water for Injection USP) Production according to API-GMP (ICH Q7), Customised products and concentrationsHedinger Purified Water Ph. Eur./USP - Butylhydroxytoluol Ph. Eur. / USP-NF / JPE
- Customised (re-)packaging
Packaging of customer supplied products, Classified clean-room conditions; 1 class C clean-room & 7 class D clean-rooms for toxic, flammable, corrosive and non-hazardous products; Customised labelling; GMP documentation - Disodium Edetate Ph. Eur./USP
VERSENE NA Chelating Agent - Glycerol 85% Ph. Eur.
(produced with Purified Water Ph. Eur. / USP)Hedinger Purified Water Ph. Eur./USP - Glycerol 85% Ph. Eur./JP LA/API/ parenteral grade
(produced with Highly Purified Water Ph. Eur.)Parenteral gradeHedinger Purified Water Ph. Eur./USP - Glycerol Ph. Eur./USP 99.7% (synth.)
- Glycerol Ph. Eur./USP/JP 99.7% (synth.) LA parenteral gradeParenteral grade
- Hydrogen Peroxide Solution (30%) Ph. Eur. API grade
- Isopropyl Alcohol 70% Biocidal Product
(produced with Purified Water Ph. Eur. / USP)Hedinger Purified Water Ph. Eur./USP - Isopropyl Alcohol 70% (V/V) API grade/USP
Isopropyl Rubbing Alcohol USP (produced with Purified Water Ph. Eur./USP)Hedinger Purified Water Ph. Eur./USP - Isopropyl Alcohol GMP Ph. Eur./USP/JP
(pharmaceutical starting material/biocidal active substance) - Macrogols Ph. Eur./USP (NF)
CARBOWAX SENTRY, Polyethylene Glycols - Metacresol Ph. Eur. / USP parenteral gradeParenteral grade
- Petroleum Spirit DAB
(boiling range 40°C to 60°C) - Propylene Glycol Ph. Eur./USP
- Propylene Glycol Ph. Eur./USP/JP
- Propylene Glycol Ph. Eur./USP/JP parenteral gradeParenteral grade
- Purified Water Ph. Eur.Hedinger Purified Water Ph. Eur./USP
- Sodium Hypochlorite solution 1% DAC/API gradeHedinger Purified Water Ph. Eur./USP
- Sodium Hypochlorite solution 3% DAC/API gradeHedinger Purified Water Ph. Eur./USP
Parenteral Grades
- Acetic Acid Glacial (99.9%) Ph. Eur./USP/JP parenteral gradeParenteral grade
- Glycerol 85% Ph. Eur./JP LA/API/ parenteral grade
(produced with Highly Purified Water Ph. Eur.)Parenteral gradeHedinger Purified Water Ph. Eur./USP - Glycerol Ph. Eur./USP/JP 99.7% (synth.) LA parenteral gradeParenteral grade
- Metacresol Ph. Eur. / USP parenteral gradeParenteral grade
- Propylene Glycol Ph. Eur./USP/JP parenteral gradeParenteral grade
API Grades
- Glycerol 85% Ph. Eur./JP LA/API/ parenteral grade
(produced with Highly Purified Water Ph. Eur.)Parenteral gradeHedinger Purified Water Ph. Eur./USP - Acetic Acid 80% API grade
(produced with Purified Water Ph. Eur./USP)Hedinger Purified Water Ph. Eur./USP - Hydrogen Peroxide Solution (30%) Ph. Eur. API grade
- Isopropyl Alcohol 70% Biocidal Product
(produced with Purified Water Ph. Eur. / USPHedinger Purified Water Ph. Eur./USP - Isopropyl Alcohol 70% (V/V) API grade/USP
Isopropyl Rubbing Alcohol USP (produced with Purified Water Ph. Eur./USP)Hedinger Purified Water Ph. Eur./USP - Sodium Hypochlorite solution 1% DAC/API gradeHedinger Purified Water Ph. Eur./USP
- Sodium Hypochlorite solution 3% DAC/API gradeHedinger Purified Water Ph. Eur./USP
Dow
- Propylene Glycol Ph. Eur./USP
- Propylene Glycol Ph. Eur./USP/JP
- Propylene Glycol Ph. Eur./USP/JP parenteral gradeParenteral grade
- Disodium Edetate Ph. Eur./USP
VERSENE NA Chelating Agent - Macrogols Ph. Eur./USP (NF)
CARBOWAX SENTRY, Polyethylene Glycols
Olin (Blue Cube)
- Glycerol Ph. Eur./USP 99.7% (synth.)
- Glycerol Ph. Eur./USP/JP 99.7% (synth.) LA parenteral gradeParenteral grade
- Glycerol 85% Ph. Eur.
(produced with Purified Water Ph. Eur. / USP)Hedinger Purified Water Ph. Eur./USP - Glycerol 85% Ph. Eur./JP LA/API/ parenteral grade
(produced with Highly Purified Water Ph. Eur.)Parenteral gradeHedinger Purified Water Ph. Eur./USP
INEOS Phenol
- Aceton Ph. Eur. / USP-NF / JPE
INEOS Acetone SQ
Shell Chemicals
- Isopropyl Alcohol GMP Ph. Eur./USP/JP
(pharmaceutical starting material/biocidal active substance) - Isopropyl Alcohol 70% Biocidal Product
(produced with Purified Water Ph. Eur. / USP)Hedinger Purified Water Ph. Eur./USP - Isopropyl Alcohol 70% (V/V) API grade/USP
Isopropyl Rubbing Alcohol USP (produced with Purified Water Ph. Eur./USP)Hedinger Purified Water Ph. Eur./USP - Petroleum Spirit DAB
(boiling range 40°C to 60°C) - Product information
ARKEMA
- Hydrogen Peroxide Solution (30%) Ph. Eur. API grade
INEOS Acetyls
- Acetic Acid Glacial (99.9%) Ph. Eur./USP/JP
- Acetic Acid Glacial (99.9%) Ph. Eur./USP/JP parenteral gradeParenteral grade
- Acetic Acid 80% API grade
(produced with Purified Water Ph. Eur./USP)Hedinger Purified Water Ph. Eur./USP - Acetic Acid customised aqueous solutions
(produced with Purified Water Ph. Eur./USP)Hedinger Purified Water Ph. Eur./USP
LANXESS
- Metacresol Ph. Eur. / USP parenteral gradeParenteral grade
- Butylhydroxytoluol Ph. Eur. / USP-NF / JPE
Hedinger
- Purified Water Ph. Eur.Hedinger Purified Water Ph. Eur./USP
- Sodium Hypochlorite solution 1% DAC/API gradeHedinger Purified Water Ph. Eur./USP
- Sodium Hypochlorite solution 3% DAC/API gradeHedinger Purified Water Ph. Eur./USP
- Aqueous solutions
(formulated with Highly Purified Water Ph. Eur./Water for Injection USP) Production according to API-GMP (ICH Q7), Customised products and concentrationsHedinger Purified Water Ph. Eur./USP - Customised (re-)packaging
Packaging of customer supplied products, Classified clean-room conditions; 1 class C clean-room & 7 class D clean-rooms for toxic, flammable, corrosive and non-hazardous products; Customised labelling; GMP documentation