Oxycodone impurity standard

British Pharmacopoeia Commission

Revision date : 2014-12-09

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GHS07 GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

General Information

Revision date

2014-12-09

Product name

Oxycodone impurity standard

1.2.1 Relevant identified uses

Reference material for laboratory use only

1.2.2. Uses advised against

No further relevant information available

Emergency telephone

+44 (0) 20 3080 6561 (Monday - Friday 8am - 5pm

Icons in SDS

GHS07 GHS08 M009

Company Information

company name

British Pharmacopoeia Commission

e-mail address of the competent person responsible for the Safety Data Sheet

bpcrs@mhra.gov.uk

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H302, H302+H332, H317, H332, H334

Hazard statements

Code

Statements

H302

Harmful if swallowed

Section 2

CLP CLASSIFICATION

GHS08 health hazard Resp. Sens. 1 H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled. GHS07 Acute Tox. 4 H302 Harmful if swallowed. Acute Tox. 4 H332 Harmful if inhaled. Skin Sens. 1 H317 May cause an allergic skin reaction.

EU Classification

Directive 67/548/EEC or Directive 1999/45/EC Xn; Harmful R20/22: Harmful by inhalation and if swallowed. Xn; Sensitising R42/43: May cause sensitisation by inhalation and skin contact. · Information concerning particular hazards for human and environment: The product has to be labelled due to the calculation procedure of the "General Classification guideline for preparations of the EU" in the latest valid version.

Classification system

The classification is according to the latest editions of the EU-lists, and extended by company and literature data.

2.2 Label elements

Labelling according to Regulation (EC) No 1272/2008 The product is classified and labelled according to the CLP regulation.

Hazard pictograms

GHS07 GHS08

Signal word

Danger

Hazardous Ingredients

Oxycodone hydrochloride 14-Hydroxycodeinone

Hazard statements

H302+H332 Harmful if swallowed or if inhaled. H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled. H317 May cause an allergic skin reaction.

Precautionary statements

P285 In case of inadequate ventilation wear respiratory protection. P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves/protective clothing/eye protection/face protection. P321 Specific treatment (see on this label). P304+P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

PBT Substances

Not applicable

vPvB Substances

Not applicable

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