This standard specifies the specifications, technical indicators and requirements, test methods, inspection rules, criterion rule and requirements of product packaging, labeling, transportation and storage of empty HPMC capsules.This standard is applicable to empty HPMC hard capsules made of HPMC and auxiliary materials and HPMC should meet Standard of HPMC (hydroxypropyl methylcellulose) for capsules.
The empty HPMC capsule is a cylindrical hard capsule with a cap and body section, and various locking structures. Capsules are divided into 00#, 0 #, 1 #, 2 #, 3 #, 4 #, 5 # and other special sizes according to their capacity. Conventional extended capsules are represented by el, such as 0# el. Also, the capsule can be divided into three types: transparent (both sections do not contain opacifier), opaque (both sections contain opacifier), and translucent (only one section contains opacifier).
Physical and chemical indicators of capsules
|Identification||-||Conforms to composition|
|Disintegration time||min||≤ 20|
|Loss on drying||%||8.0|
|Ignition residue (transparent)||%||≤ 3.0|
|Ignition residue (translucent)||%||≤ 5.0|
|Ignition residue (opaque)||%||≤ 6.0|
|Arsenic salt||mg/kg||≤ 2|
If ethylene oxide sterilization or the paraben antibacterial agents are used during production, shall add the detection and control of the corresponding project.
|Total Bacterial count||cfu/g||≤ 1000|
|Yeast and Moldscount||cfu/g||≤ 100|
90% sulfuric acid solution, ninhydrin test solution.
take 1.0g of the product, add 100ml of boiling water, stir it with a magnetic stirrer of 25mm length, and there should be a suspension. Cool the solution down to 10 ° C with stirring, the solution should be clear or slightly turbid. If the solution is clear, take it for the test solution, If not, take some, and centrifuge the solution at 2500 rpm for 2 minutes, and take the supernatant for the test solution. Take 0.1ml of test solution, add 9ml of 90% sulfuric acid solution, shake, and heat the solution in a water bath for 3 minutes, then immediately cool it down in an ice bath. Carefully add 0.6ml of ninhydrin test solution, shake, and leave the solution aside under room temperature, the solution should turn red first, and then turns into purple in 100 minutes. Precisely measure 50 ml of the test solution, place it in a beaker, add 50 ml of water, magnetically stir, heat, and the temperature will raise at 2-5 ° C / min. Write down the temperature when the solution forms turbid, and the flocculation temperature should be higher than 50 ° C.
Instruments and excipients
a disintegration time tester (temperature is controlled at 37 ± 1 °C), talcum powder
take 6 capsules, fill them with talcum powder (the filled capsule shall not float on the water), lock the capsules, and then place capsules in the glass tube of the hanging basket, put on the baffle. All the capsules should be completed disintegrated in 20 minutes, and there should be no other things left on the sieve excepting for the broken capsule shell. If some of the disintegrated capsules cannot pass through the sieve, but they are softened or lightly float on the water, it is also in accordance with the regulations. If one of the capsules does not disintegrate, should test another 6 capsules, and all of them should meet the requirements.
take 1.0g of this product, add 1.0g of calcium hydroxide, mix, and then add water and stir. After drying, carbonize the solution with small fire, then ignite it at 600 °C under it is completely ashed. Leave it for cooling down, and then add 5ml of hydrochloric acid and 23ml of water for dissolution, and check accordingly.
The measuring method of tightness, brittleness, loss on drying the residue on ignition, Pb, microorganisms, inspection rules, criterion rule, and product packaging, labeling, transportation, storage requirements are the same as those for empty gelatin capsule standard.