Standards

YBB 00242004-2015 Combinational Closures of PP for Plastic Infusion Containers (with ring-pull)

This standard applies to polypropylene composite caps for plastic infusion containers. The composite caps consist of a pull-ring-style outer cap (mainly made of polypropylene), an inner cap (mainly made of polypropylene), and a gasket. The polyisoprene gasket in the composite cap should comply with the requirements of the Pharmaceutical Synthetic Polyisoprene Gasket (YBB00232004-2015).

Publish Date: 2015-08-11

YBB 0025-2003 Boli Keli Zai 121℃ Naixhuixing Cedingfa He Fengji Tests and classification for hydrolytic resistance of glass graina at 121℃

Publish Date: 2003-10-28

YBB 0024-2003 121℃Neibiaomian Naishuixing Cedingfa He Fenji Tests and classification for hydrolytic resistance of interior surfaces

Publish Date: 2003-10-28

YBB 00172005-2015 Limits of Arsenic Antimony Lead and Cadmium Release from Medicinal Glass

This standard applies to all kinds of glass containers and materials that come into direct contact with medicines.

Publish Date: 2015-08-11

YBB 00262005-2015 Determination of Ash for Rubber

This standard is applicable to the determination of ash content in medicinal halogenated butyl rubber and polyisoprene rubber stoppers and gaskets

Publish Date: 2015-08-11

YBB 00192002-2015 Laminated Film and Pouches (BOPP/LDPE) for Pharmaceutical Packaging

This product refers to a film made by laminating biaxially oriented polypropylene (BOPP) and low-density polyethylene (LDPE) with an adhesive, as well as bags made from the aforementioned film through heat sealing. This standard applies to composite films and bags used for packaging solid drugs.

Publish Date: 2015-08-11

YBB 0003-2003 Rongxue Jianchafa Tests for hemolysis

Publish Date: 2003-10-28

YBB 00112003-2015 Test for Tensile Properties

This method is applicable to the determination of the tensile strength and elongation at break of plastic films and sheets (with a thickness not exceeding 1 mm)

Publish Date: 2015-08-11

YBB 00172003-2015 Test for Internal Pressure Resistance

This law applies to the determination of the resistance to internal pressure of pharmaceutical glass containers

Publish Date: 2015-08-11

YBB 00032005-2015 Infusion Bottles Made of Soda Lime Glass

This standard applies to sodium-calcium glass infusion bottles that have undergone neutralization treatment on their inner surfaces and are used to package large-capacity injectable solutions.

Publish Date: 2015-08-11

YBB 00112002-2015 PP Bottles for Oral Solid Preparation

This standard applies to plastic bottles for oral solid preparations, which are mainly made of polypropylene (PP) and produced by injection-blow molding

Publish Date: 2015-08-11

YBB 00312004-2015 Test for Residual Solvent of Packaging Materials

This law applies to the determination of residual solvents in drug packaging materials. Residual solvents in drug packaging materials refer to organic volatile substances that are used in the raw materials and production processes of drug packaging materials, but cannot be completely removed during the production process of drug packaging materials. The residual amount of organic solvents in drug packaging materials shall comply with the provisions under each variety. The types of solvents to be tested shall be determined according to the characteristics of the product formulation and production process, and are not limited to the solvents listed in this standard as examples.

Publish Date: 2015-08-11