Inorganic Colourants for Pharma

Common Name	Iron Oxide Red	Iron Oxide Yellow	Iron Oxiide Black	Iron Oxide Brown
Colour Index No	77491	77492	77499	77491/92/99
E.E.C. No	E-172	E-172	E-172	E-172
CAS No	1309-37-1	51274-00-1	1309-38-2	1309-37-1/51274-00-1/1309-38-2
Identification of Ferric Salt	As per USP	As per USP	As per USP	As per USP
Water Soluble substance percent by mass	Max 1.00	Max 1.00	Max 1.00	Max 1.00
Acid Insoluble substances, percent by mass	Max 0.3	Max 0.3	Max 0.3	Max 0.3
Organic Colours & lakes	As per USP	As per USP	As per USP	As per USP
Mercury (mg/kg)	Max 3.0	Max 3.0	Max 3.0	Max 3.0
Arsenic (mg/kg)	Max 3.0	Max 3.0	Max 3.0	Max 3.0
Lead (mg/kg)	Max 10.0	Max 10.0	Max 10.0	Max 10.0
Assay as Fe203 as ignited basis	97.0% - 100.5%	97.0% - 100.5%	97.0% - 100.5%	97.0% - 100.5%
Microbial limit Test:
A) Total Microbial Count	NMT 50 cfu/g	NMT 50 cfu/g	NMT 50 cfu/g	NMT 50 cfu/g
B) E.Coli NMT 50 cfu/g	Absent in 10g	Absent in 10g	Absent in 10g
C) Salmonella	Absent in 10g	Absent in 10g	Absent in 10g	Absent in 10g
D) Pseudomonas	Absent in 10g	Absent in 10g	Absent in 10g	Absent in 10g
E) S.aureus	Absent in 10g	Absent in 10g	Absent in 10g	Absent in 10g
F) Yeast & Mold	NMT 50 cfu/g	NMT 50 cfu/g	NMT 50 cfu/g	NMT 50 cfu/g

Water Soluble Colourants for Pharma

Common Name	Allura Red	Tartrazine	Sunset Yellow	Brilliant Blue	Indigo Carmine	Erythrocine
2 Colour Index No	16035	19140	15985	42090	73015	45430
E.E.C. No	E 129	E 102	E 110	E 133	E 132	E 127
FD&C No	Red 40	Yellow 5	Yellow 6	Blue 1	Blue 2	Red 3
Colour Index Reference (food)	Red 17	Yellow 4	Yellow 3	Blue 2	Blue 1	Red 14
Indian Standard No.	--	1694	1695	6406	1698	1697
3 PURITY TEST
Pure Dye Content (% MIN)	85	87	87	85	85	87
Loss on Drying at 1350C & Sodium Chloride/sulphates (% MAX)	14	13	13	15	15	13
Water Insoluble Matter (% MAX)	0.2	0.2	0.2	0.2	0.2	0.2
Ether Extractable Matter (% MAX)	0.2	0.2	0.2	0.2	0.2	0.2
Subsidiary Dyes (% MAX)	3	1	3	3	1	4
Organic Compounds other than Colouring Matters (% MAX)	1.5	0.5	0.5	1.8	0.5	0.4
Unsulfonated Primary Aromatic Amines (% MAX)	0.01	0.01	0.01	0.01	0.01	N.A.
Arsenic (AS' As') PPM (MAX)	1	1	1	1	1	1
Lead (AS' Pb') PPM (MAX)	10	10	10	10	10	10
Mercury (AS' Hg') PPM (MAX)	1	1	1	1	1	1
Cadmium (AS' Cd') PPM (MAX)	1	1	1	1	1	1
Heavy Metals PPM (MAX)	40	40	40	40	40	40
pH3	Stable	Stable	Stable	Slight Fade After 10 Days	Appreciable Fade After 9 Days	Precipitate (Insoluble)
pH7	Stable	Stable	Stable	Very Slight Fade After 8 Days	Considerable Fade After 6 Days	Stable
pH8	Stable	Stable	Stable	Very Slight Fade After 6 Days	Fades Completely	Stable

Common Name	Amaranth	Carmoisine	Ponceau 4R	Quinoline Yellow WS	Brown HT	Black PN	Patent Blue V
2 Colour Index No	16185	14720	16255	47005	20285	28440	42051
E.E.C. No	E 123	E 122	E 124	E 104	E 155	E 151	E 131
FD&C No	-	-	-	-	-	-	-
Colour Index Reference (food)	Red 9	Red 3	Red 7	Yellow 13	Brown 3	Black 1	Blue 5
Indian Standard No.	--	2923	2558	--	--	--	--
3 PURITY TEST
Pure Dye Content (% MIN)	85	85	82	70	70	80	85
Loss on Drying at 1350C & Sodium Chloride/sulphates (% MAX)	15	15	18	30	30	20	15
Water Insoluble Matter (% MAX)	0.2	0.2	0.2	0.2	0.2	0.2
Ether Extractable Matter (% MAX)	0.2	0.2	0.2	0.2	0.2	0.2
Subsidiary Dyes (% MAX)	3	1	1	4	10	10	2
Organic Compounds other than Colouring Matters (% MAX)	0.5	0.5	0.5	0.5	0.7	0.8	0.5
Unsulfonated Primary Aromatic	0.01		0.01	0.01	0.01	0.01	0.01
Amines (% MAX)
Arsenic (AS' As') PPM (MAX)	1	1	1	1	3	3	3
Lead (AS' Pb') PPM (MAX)	10	10	10	10	10	10	10
Mercury (AS' Hg') PPM (MAX)	1	1	1	1	1	1	1
Cadmium (AS' Cd') PPM (MAX)	1	1	1	1	1	1	1
Heavy Metals PPM (MAX)	40	40	40	40	40	40	40
pH3	Stable	Stable	Stable	Stable	Stable	Stable	Appreciable Fade after 8 days
pH7	Stable	Stable	Stable	Stable	Stable	Stable	Appreciable Fade after 8 days
pH8	Stable	Stable	Stable	Stable	Stable	Stable	Appreciable Fade after 8 days