E4 for Empty HPMC Capsules

*It is semi-synthetic in nature, derived from plant cellulose,  

*Cross-linking problem with the excipients is totally absent since,  the polymer is free from amino acids,  

*Can be used for a variety of fill materials containing aldehydic group,  

*It readily dissolves in cold water giving a colloidal solution  owing to the reversible thermal gelation property,  

*Forms a flexible film of controlled dimensions, 

*Water does not act as a plasticiser for HPMC.


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Product Details

HPMC capsules do not contain animal-derived ingredients; they were developed about 30 years ago during the search for an equally-efficient alternative to hard gelatin capsules. Since their introduction, HPMC capsules have acquired a market share in the global empty capsule industry thanks to their natural origin, an increased demand for vegetarian products, and the capsules’ excellent stability with a variety of API’s.


Formula HPMC Specification

Hydroxypropyl Methylcellulose for Plant Capsules

(n-2)/2 

OR=-OH、-OCH3、-[OCH2CH(CH3)]nOH or-[OCH2CH(CH3)]OCH3


Plant Capsule Specification

Item

Results

Tightness

grain

≤1

Friability

grain

≤2

Disintegration time limit

min

≤15

 

Burning residue

Transparent

%

≤2

Semitransparent

%

≤4

Opaque

%

≤6

Loss on drying

%

≤8

Heavy metal

ppm

≤10

Arsenic salt

ppm

≤2

Microbial Limit

Total number of aerobic bacteria

 cfu/g

 ≤1000

 Total Mold and Yeast

 cfu/g

 ≤100

 Escherichia coli

 cfu/g

Not checked out

Total Staphylococcus aureus

 cfu/g

Not checked out


HPMC Specification

Item

Results

 

Viscosity

ML-E3

cp

2.4~3.5

ML-E4

cp

3.6~4.5

ML-E5

cp

4.6~5.5

pH


5.5~7.5

Insoluble matter in water

%

<0.4

Loss on drying

%

≤4.5

Burning residue

%

<1.2

Heavy metal

ppm

<10

Arsenic salt

ppm

<2

Methoxy(2910)

%

28.0~30.0

Hydroxypropyl(2910)

%

7.0~12.0

 

Microbial Limit

Total number of 

aerobic bacteria

 cfu/g

 ≤600

Total Mold and Yeast

cfu/g

≤60

Escherichia coli

cfu/g

Not checked out


Characteristics of plant capsules

The capsule has high transparency and good color.

Good formability and solidity after dipping in glue, which is more conducive to demoulding.

The capsule shell has uniform thickness and good toughness.

It does not contain chloroethanol, and the heavy metal indicators meet the requirements of the United States and European Pharmacopoeia.

plant capsules Characteristics of plant capsules HPMC Specification Plant Capsule


HPMC packaging and storage

Barrel or paper plastic bag lined with polyethylene film inner bag. Net weight of each bag: 25kg.

Protect from sun and rain during storage and transportation.

HPMC for Plant Capsule


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