User Support

Capsule FAQ

Pharmaceutical Capsules

Are your capsules pharmacopoeia approved?

Yes, they are. Under the 1996 revision to the Japanese Pharmacopoeia, capsules are defined as being "made using appropriate base capsule materials listed in the Japanese Pharmacopoeia."

Gelatin Capsules

How safe is pork-derived gelatin?

The pork-derived gelatin used in the manufacturing process of our gelatin capsules is sterilized by the raw material manufacturer during the manufacturing process by heating to 138°C. An administrative notice (dated April 26, 2009) issued by the Tuberculosis and Infectious Diseases Control Division of the Ministry of Health, Labor and Welfare's Health Service Bureau stated that when preparing porcine meat for consumption, cooking the meat so that the internal temperature reaches 71°C is sufficient to kill the swine influenza virus. Therefore, we believe that the pork-derived gelatin used here at Qualicaps poses no safety issues.

HPMC Capsules

Are HPMC capsules different in shape to gelatin capsules?

They are the same in length and outer diameter.

Can they be dyed?

Yes. They can be dyed using the following:
Tar-based dyes: red #2, red #102, yellow #4, yellow #5, blue #1, green #3.
Pigments: titanium oxide and colcothar iron oxide.

Please go into detail about the composition.

Hydroxypropyl methylcellulose accounts for virtually 100% of the weight of the capsule. They also include carrageenan as a gelator and potassium chloride as a gelling adjuvant.

How much of the capsule is made up of fluids?

Between 4% and 6%.

Do you have any information on the stability of the capsules in relation to pharmaceutical products?

No.

Do you have any material on the elution properties of the capsules?

Yes.
Please contact Qualicaps Sales for more details.

Can they be band-sealed?

Yes, the capsules can be band-sealed using HPMC. A special band-sealer is used during production. Click here for information on the capsules sealer.

Can the capsules be filled with fluids?

Yes, they can be filled with many fluids except PEG400, glycerin and propylene glycol.
Please click here for details about fillers.

Do you have any information on cutting when used as an inhalant container?

No.

Can HPMC capsules be used overseas?

Yes, they can. However, each country and region has its own regulations. Be sure to consult one of our sales representatives in advance.