IS 19085 : 2024 Glass Containers for Homoeopathic Pharmaceutical Preparations - Specification

ICS 11.120.99

AYD 07

1 SCOPE

This standard prescribes the materials, requirements and testing methods of glass bottles used for different dosage forms in homoeopathy.

This document applies to phials, drop-dispensing glass bottles and screw-neck glass bottles used in homoeopathic pharmacies. Together with the corresponding closure systems, they are used for packaging and dispensing of homoeopathic pharmaceutical preparations in solid and liquid dosage forms.

2 REFERENCES

The standards listed in Annex A contain provisions which, through reference in this text, constitute provisions of this standard. At the time of publication, the editions indicated were valid. All standards are subject to revision and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent edition of these standards.

IS No.	Title
IS 1070 : 2023	Reagent grade water - Specification (fourth revision)
IS 2303	Grading glass for alkalinity
(Part 1/Sec 2) : 2021/ISO 720 : 2020	Hydrolytic resistance of glass grains, Section 2 Determination and classification of hydrolytic resistance at 121 °C (third revision)
(Part 2) : 2018/ISO 4802-1 : 2016	Hydrolytic resistance of glass containers - Determination by titration method and classification (second revision)
IS 6945 : 1973	Code of practice for packaging glass and glassware
IS 8932 : 1978	Specification for preformed metal screw caps for glass containers
IS 9153 : 2023	Methods of polariscopic examination of glassware (first revision)
IS 9806 : 2001	Methods of test for and permissible limits of toxic materials released from ceramicware, vitreous enamelware, glassware and glass-ceramicware in contact with food (first revision)
IS 11539 : 2018/ISO 8113 : 2004	Method of vertical load test for glass containers (first revision)
IS/ISO 11418-1 : 2016	Containers and accessories for pharmaceutical preparations Part 1 Dropdispensing glass
IS/ISO 11418-2 : 2016	Containers and accessories for pharmaceutical preparations Part 2 Screwneck glass bottles for syrups
IS/ISO 11418-3 : 2016	Containers and accessories for pharmaceutical preparations Part 3 Screwneck glass bottles (Veral) for solid and liquid dosage forms
IS/ISO 11418-7 : 2016	Containers and accessories for pharmaceutical preparations Part 7 Screwneck vials made of glass tubing for liquid dosage forms
IS 11930 : 2018/ISO 7459 : 2004	Glass containers - Thermal shock resistance and thermal shock endurance - Test methods (first revision)
IS 19084 : 2024	Plastic containers and closures for homoeopathic pharmaceutical preparations - Specification