CELLETS® – MCC Spheres

100 µm – 1400 µm

CELLETS® – MCC Spheres – are perfect starter beads for multi-particulate dosage forms, tablets, minitablets and capsule applications.

CELLETS® are made from 100% certified MCC (Microcrystalline Cellulose) and pure water, only. They are inert, tasteless and odorless. With strong physical properties, such as zero friability, high degree of sphericity, best monodispersity, and low swelling index, CELLETS® are extremely versatile.

All CELLETS® products have analyzed quality according to Ph.Eur., USP/NF and JPE. High-level certified producer from Germany. Special sizes on request.

CELLETS® – MCC Spheres made in Germany have strongest impact in scientific publications and marketed pharmaceutical formulations.

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Your benefits: CELLETS® – MCC Spheres

supporting micropellet solutions from 100 µm to 200 µm: perfect for highly active low dosage API.
enabling controlled release and combinatory products
assisting formulations of sensitive actives due to the inertness of MCC
simplifying and accelerating production processes due to low water solubility
unlocking unseen rheological behavior as a matter of best sphericity – ideal for capsules
showing excellent compactibility due to the high plasticity
improving efficiency of coating processes thanks to high abrasion resistance

CELLETS® 100 – CELLETS® 1000	TEST METHOD
Appearance	White, nearly white or beige, hard and almost spherical particles	Cellets Standard
Solubility	Insoluble in water, ethanol, acetone and toluene, diluted in acids Ph.Eur. and sodium hydroxide solution (50 g/l)	Ph.Eur.
Odor	Odorless	Ph.Eur., JPE

CELLETS® 100 – CELLETS® 1000

TEST METHOD

Appearance

White, nearly white or beige, hard and almost spherical particles

Cellets Standard

Solubility

Insoluble in water, ethanol, acetone and toluene, diluted in acids Ph.Eur. and sodium hydroxide solution (50 g/l)

Ph.Eur.

Odor

Odorless

Ph.Eur., JPE

	CELLETS® 100	CELLETS® 150	CELLETS® 200	CELLETS® 350	CELLETS® 500	CELLETS® 700	CELLETS® 1000	TEST METHOD
Particle size distribution (≥ 85 %)	100-200 µm	150-300 µm	200-355 µm	350-500 µm	500-710 µm	700-1000 µm	1000-1400 µm	Cellets Standard

CELLETS® 100

CELLETS® 150

CELLETS® 200

CELLETS® 350

CELLETS® 500

CELLETS® 700

CELLETS® 1000

TEST METHOD

Particle size distribution
(≥ 85 %)

100-200 µm

150-300 µm

200-355 µm

350-500 µm

500-710 µm

700-1000 µm

1000-1400 µm

Cellets Standard

	All standard sizes	TEST METHOD
Loss on drying	≤ 7.0 %	Ph.Eur., USP/NF, JP, JPE
Bulk density (g/m3)	0.80 ± 5 % (for information only)	Ph.Eur., USP/NF, JP
Sphericity degree (average)	≥ 0.90	Cellets Standard
Friability (%)	0	Cellets Standard
Swelling index (ml/g)	≤ 2	Cellets Standard

All standard sizes

TEST METHOD

Loss on drying

≤ 7.0 %

Ph.Eur., USP/NF, JP, JPE

Bulk density (g/m3)

0.80 ± 5 % (for information only)

Ph.Eur., USP/NF, JP

Sphericity degree
(average)

≥ 0.90

Cellets Standard

Friability (%)

Cellets Standard

Swelling index (ml/g)

≤ 2

Cellets Standard

	All standard sizes	TEST METHOD
Identification infrared absorption	passed	Ph.Eur., USP/NF, JP
Identification zinc chloride test	passed	Ph.Eur., USP/NF, JP, JPE
Degree of polymerization	≤ 350	Ph.Eur., USP/NF, JP
pH value	5.0 – 7.5	Ph.Eur., USP/NF, JP, JPE
Conductivity (µS/cm)	≤ 75	Ph.Eur., USP/NF, JP, JPE
Ether soluble substances	≤ 0.05 %	Ph.Eur., USP/NF, JP, JPE
Water soluble substances	≤ 0.25 %	Ph.Eur., USP/NF, JP, JPE
Heavy metals (ppm)	≤ 10	JP, JPE
Sulfated ash / Residue on ignition [%] determined on 1 g)	≤ 0.1	Ph.Eur., USP/NF
Sulfated ash / Residue on ignition [%] determined on 2 g)	≤ 0.1	JP, JPE

All standard sizes

TEST METHOD

Identification infrared absorption

passed

Ph.Eur., USP/NF, JP

Identification zinc chloride test

passed

Ph.Eur., USP/NF, JP, JPE

Degree of polymerization

≤ 350

Ph.Eur., USP/NF, JP

pH value

5.0 – 7.5

Ph.Eur., USP/NF, JP, JPE

Conductivity (µS/cm)

≤ 75

Ph.Eur., USP/NF, JP, JPE

Ether soluble substances

≤ 0.05 %

Ph.Eur., USP/NF, JP, JPE

Water soluble substances

≤ 0.25 %

Ph.Eur., USP/NF, JP, JPE

Heavy metals (ppm)

≤ 10

JP, JPE

Sulfated ash / Residue on ignition [%]
determined on 1 g)

≤ 0.1

Ph.Eur., USP/NF

Sulfated ash / Residue on ignition [%]
determined on 2 g)

≤ 0.1

JP, JPE

	All standard sizes	TEST METHOD
Total aerobic microbial count	≤ 1,000 CFU/g	Ph.Eur., USP/NF, JP, JPE
Fungi / moulds and yeasts	≤ 100 CFU/g	Ph.Eur., USP/NF, JP, JPE
E. coli Ps. aerugin. St. aureus	absence in 1 g sample	Ph.Eur., USP/NF, JP, JPE
Salmonella species	absence in 10 g sample	Ph.Eur., USP/NF, JP, JPE

All standard sizes

TEST METHOD

Total aerobic microbial count

≤ 1,000 CFU/g

Ph.Eur., USP/NF, JP, JPE

Fungi / moulds and yeasts

≤ 100 CFU/g

Ph.Eur., USP/NF, JP, JPE

E. coli Ps. aerugin. St. aureus

absence in 1 g sample

Ph.Eur., USP/NF, JP, JPE

Salmonella species

absence in 10 g sample

Ph.Eur., USP/NF, JP, JPE

CELLETS® – MCC Spheres

Your benefits: CELLETS® – MCC Spheres

Ph.Eur.

USP-NF

JP/JPE

ChP

Technical specification

Physical parameters

Chemical parameters

Microbiological parameters

Product consultation

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