.-S Rev.01) Form Penyelidikasi Hasil Uji Diluar Spesifikasi (HULS) Parameter Kompendial

.-S5.03-001 Rev.01) Form Penyelidikasi Hasil Uji Diluar Spesifikasi (HULS) Parameter Kompendial

/R K E R J A

,nen#. QC-FM-S5.03-004 Rev.OO

FORIVI HASIL UJI LUAR SPESIFIKASI fHULS) PARAMETER KOMPENDIAL

Phaprifs

OOSNo. \d/UOi/ m 1)0}^

INFORMASI DASAR/ BASIC INFORMATION :DRawMaterial d^Ruahan

•Stabilitas

• & m n u l Jenis sampel

Nama sampel No batch/ No Lot Analis yang mengerjakan

0 Lingkungan

I& 0,0 Fop 3

INFORMASI HULS/OOS INFORMATION Uralan Kejadlan

>

Parameter Standar

• 15-07.

A. INVEST!GAS!

Investigasi Hasil Keterangan

1. Apakah perhitungan dan intarpretasi hasil sudah benar E V a • Tidak • NA 2. Apakah parameter instrumen sudah selesai Efva • Tidak • NA 3. Apakah instrumen terkalibrasi B y a • Tidak • NA 4. Metode sampling

4.

a. Apakah sampling sudah dilakukan secara benar [^Ya • Tidak • NA 4.

b. Apakah sampel yang diambil representatif QVa • Tidak • NA 4.

c. Apakah kondisi pengambilan sampel dapat menjaga

Integritas sampel • Tidak • NA

4.

a. Apakah kondisi penyimpanan sampel dapat menjaga

integritas sampel • ' V a • Tidak • NA

4.

e. Berapa lama sampel disimpan sampai dianalisa ..C?.hari 5. Kualifikasi Analis

5.

a. Apakah analis sudah di-training dan hasilnya baik 0 Y a • Tidak • NA 5.

b. Apakah analis tersebut pernah menghasilkan data O O S di analisa

D Y a S ' Tidak O NA 5.

b. Apakah analis tersebut pernah menghasilkan data O O S di analisa

6. Penyimpanan terhadap prosedur/ metodeyang digunakan

Jenis prosedur/ metodeyang digunakan No dokumen Hasil Paraf &Tgl U - o^cj^lci -ox Qf*/IS • T M S

/ Apakah metode analisa sudah tervalidasi |E3Ya • Tidak G NA

7. Reagent/Fasa gerak ** yang digunakan ^ No Nama Reagent/ Fasa gerak** Pabrikan/ Ex. Tgl.datang Hasil Paraf &Tgl

1. a ' M S D T M S

1. . rdioij

a ' M S D T M S

2, nfMS D T M S

2, nfMS D T M S

3. a ' M S D T M S

3. a ' M S D T M S

* paraf/ inisial/ tgl

** coret jlka tidak diperlukan

Hal 1 dari 3

Lampiran 3 (QC-IK-S5.03-001 Rev.01) Form Penyeiidil<asl Hasil Uji Diluar Spesifikasi (HULS) Parameter K

F O R M U L I R K E R J A

Dokumen #. QC-FI\yi-S5.03-004 Rev.OO Judul:

FORM HASIL UJI LUAR SPESIFIKASI (HULS) PARAMETER KOMPENDIAL

Phapr%

8. Pipet/labutakar** yang digunakan

No Jenis volume pipet/labu takar** Pembuat/ Ex Terkalibrasi

Hasil Paraf & Tgl No Jenis volume pipet/labu takar** Pembuat/ Ex

Ya Tidak Hasil

r

1. aW viur loo ml ^• 31V1S • TMS

2. U i h i i i l ^ U f W /vil eg- • 31VIS • TMS

3. • a'MS • TMS

4. • • • MS D T M S

w

9. Standar yang digunakan

No Nama standar yang digunakan Pabrikan Kadaluwarsa Hasil Paraf & Tgl

1. E f M S • TMS

2. E T M S • TMS

3. • MS • TMS

10. Peralatan/ Instrumen utama yang digunakan

No Nama Alat/ Instrumen utama yang digunakan Pabri kan Tgl terakhir kalibrasi

Tgl kalibrasi

berikutnya Hasil Paraf & Tgl

r

1. C3^MS • TMS

r

2.

1

^{—^-^-1}

• MS • TMS J

3. • MS • TMS

Jenis Investigasi Laboratorium Hasil Hasil Paraf & Tgl 11. Pembuatan larutan sampel sesuai dengan prosedur E f Ya • Tidak 0 M S • TMS

a. Apakah alatyangdigunakan pernah bermasalah

sebelumnya • Ya ^T\dak E T M S n TMS

b. Apakah sistem sudah memenuhi suitability criteria B'^a • Tidak [3'MS • TMS c. Apakah tampllan hasil analisa dalam kondisi baik EfYa • Tidak Q M S • TMS

12. Kesesualan pipet volume/labu takar yang digunakan [TYa • Tidak Q M S • TMS ^^^/m' IS 13. Pembuatan larutan standar sesuai dengan prosedur Q^Ya • Tidak Q M S n TMS

14. Kesesualan sampel yang diuji IZfYa • Tidak Q M S • TMS

15. Pemeriksaan penanganan dan preparasi sampel [TfYa • Tidak Q M S • TMS Metode yang sama digunakan untuk produkyangsama

16. no batch ; — • Ya Q ^ i d a k j o MS • TMS

17. Lain - lain :

Akarmasalah/ root cause dan kesimpulan/

conclusion

n Jelas :

a ' Tidak jelas :

• Analis sama

(^Analis beda Rekomendasi

Q R E T E S T I N G BTRESAMPLING

• DUPLO

• investigasi lanjutan di Baglan Produksi

C a t a l a n / n o t e :

* paraf/inisial/tgl

** coret jika tidak diperlukan

Hal 2 dari 3

^.03-001 Rev.01) Form Penyelidiicasi Hasil UJI Diluar spesiriRasi (HULS) parameter Kompenaiai

i R J A

> QC-FM-S5.03-004 Rev.OO Phapms

FORM HASIL UJI L U A R S P E S I F I K A S I (HULS) P A R A M E T E R KOMPENDIAL

/ D E T E S T I N G A T A U R E S A M P L I N G

Infomiasi Kondisi Pengujian Parameter Pengujian

1. Analis O Sama

0 Berbeda: ^\<J\&d 2. Kondisi Pengujian

a. Alat/lnstumen B Sama O Berbeda : b. Reagent/Fasa gerak** & Sama

• Berbeda:

Hasil Pengujian b. Reagent/Fasa gerak** & Sama

• Berbeda:

c. Standar Sama

• Berbeda:

d. Sampel • Sama , .

B ' Berbeda : iompiipq U'fln(| i k^oh 3. Lain-lain

C . K E S I M P U L A N

H' Hasil Pengujian Memenuhi Syarat; Hasil pengujian pertama yang tidak memenuhi syarat (HULS) dinyatakan tidak berlaku (invalid) dan hasil pengujian ulang digunakan sebagai hasil akhir pemeriksaan

Hasil Pengujian Tidak Memenuhi Syarat:

(Confimi HULS) prik.^ ( s » ^ ra-oaj

Hasil pengujian pertama yang tidak memenuhi syarat (HULS) dinyatakan tetap berlaku (valkj) dan hasil pengujian ulang memperkuat hasil pemeriksaan (CONFIRM HULS)

D. A K A R P E R M A S A L A H A N D A N T I N D M ^ A N P E R B A I K A N S E R T A P E N C E G A H A N

A K A R P E R M A S A L A H A N T I N D A K A N P E R B A I K A N D A N P E N C E G A H A N - HPOI Pemt^^<f««r^ gr<«M per fhcU foon 4b%- - Ptf>yn'<VEu«o Uhi^ l*>i^ f"^ WTap cetak- Am^ .

E . C A T A T A N :

- fWNnklJtfln b*W«^ (nw \ t^lwfe^ V**"**- z^*- cjfw?- Mr.

Dilaporkan oleh spesialis laboratorium

( )

Diperiksa dan disetujui oleh Ass. Man QC

( )

F. KEPUTU8AN

Catatan Man. QO: Release

• Reject

• Investigasi lanjut

Disetujui oleh Manager QO

( )

*paraf/inisia[/tgl

**coret jika tidak diperlukan

Hal 3 dari 3

7

>

'4c

10'/ 76A

6P0

1

Pengendalian & Pemastian Mutu PT Pliapros Tbk Semarang

H P L C 7

S A I V I P L E I N F O R M A T I O N

/?ple Name jmple Type -Toe. Chnl. Descr.

Injection Volume Run Time

Amaropo Plus 16095003 granul User Name Unknown

W2489 ChA 280nm 10.00 ul

5.0 Minutes

Date Acquired Acq. Metliod Set Date Processed No. Spesifikasi No. Protap

Sad Pudiyastuti (0279) 01/Oct/2018 11:11:01 WIT, Vit C Vit E

01/Oct/2018 11:16:06 WIT, Inti ( 1 0 - 0 9 5 K I - 0 2 )

TS (10 - 095 K - 0 2 ) inti (11 - 095 Kl - 02)

TS (11 - 0 9 5 K - 0 2 )

0.70

0.60

0.50

0.40-1

0.30-i

0.20-

0.10 -1

0.00-1

0.00 0.50 1.00 1.50 2.00 2.50 3.00

Minutes

System Suitability Summary Results Name: Ascorbic a c i d

3.50 4.00 4.50 5.00

Sample Name Name RT Area USP

Tailing

USP Plate Count

Sample Weigfit

Amount (%) 1 Amaropo Hus 16095003 granul Ascorbic acid 1.814 7561150.498 0.7 979 1.00046 101.797 2 Amaropo Plus 16095003 granul Ascorbic acid 1.818 7555962.951 0.7 982 1.00046 101.727

Mean 101.762

System Suitability Summary Results Name: Vitamin E

Sample Name Name RT Area USP Tailing

USP Plate Count

USP Resolution

Sample Weight

Amount (%) 1 Amaropo Rus 16095003 granul Vitamin E 3.924 369359.399 1.5 2493 7 1.00046 108.101 2 Amaropo Rus 16095003 granul Vitamin E 3.927 370292.998 1.4 2506 7 1.00046 108.374

IVlean 108.237

User Name: Sad Pudiyastuti (0279)

Pongondalian & Pf

Ssimplo h4sime

Proc Ohnl. Oesor rrijeotion Volume Run Xim^

lastian Mutu Rhapros "Tbk Sef,

HRLC 7 , I N F O R A T 1 O N

s t d Vit C Vit E Stsindard

Ch/\>m -lO.OO ul S.O Minutes

LJs@r Name Date Acquired /\cq IVletnod Set Date Processed

Sad Pudiyastuti

(02rs) oi/oct/20ia 10:3e;3r wrr,

Vit C Vit E

01/Oct/2018 ii:T-*:4s wrr.

::/&5..-S55:=52;-;

.Oc+ 2818 S-02

4 9 . 9 S 6 nig

•'•••02 ••••955= 109. 3";

Oct 2918 8:09

190,016 mq

2 . s o A/fnutes

S y s t e m S u i t a k v i i i t y S u m m a r y R e s u l t s

i Sample Mame Mame RX { Area USP

"Tailing

USP Plate Count

Amount (%)

1

\d Vit C Vit E Ascortaic acid

i.eo9 ^{7.410021 0,7}

^{e i 5}

i o o . 3 i e

2

Std Vit C Vit E AscortaiG acid

1 . s o ©

^•74QSO&4. 30s

0.7 9 1 2 100 3 1 6

3 Std Vit C Vit E 1 AscortDic acid

1 . s o a 7 - s i s s e - 4 - r s 3 0.7

919 1 100.316 Std Vit C Vit E Ascorbic acid

1

.SOS

7 4 3 4 2 8 1 - 4 4 4 ^0.7

^{91 Q}

^100.

^{31 6}

5

Std Vit C Vit E Ascort»ic acid T

. a i 1 7 4 2 2 1 1 4. 0 3 e ^0.7

9 1 2 • 100.316

e

Std Vit C Vit E Ascort>ic acid

1 a i o 7404 3es. 282 0.7

922 100.316

IVIaan

T . a o s 7 4 4 7 7 0 2 6 0 2

Std. Dev

0.001 4 7 5 3 6 . 4SS 1 . . . .. ....

% RSD

0.068 0 . 6 3 8 1 j

$ y s * e m S u i t a b i l i t y S u m m a r y R e s u l t s N a m e : V i t a m i n E

Sample r>lame Islam e RT Area USP Tailing

USP Plate Count

USP Resolution

Amount

<%) 1 Std Vit C Vit E Vitamin E 3.925 3SS070. SOS 1.S

1.4

2S12 7 103.S71

2 Std Vit C Vit

e

Vitamin E 3.923 I 3S522S 94S 1.S

1.4 2521 7

103.

971

3 Std Vit C Vit E Vitamin E 3.921 356S74 799 1.5 2505 7

103.

971 4 Std Vit C Vit E Vitamin E 3.925 353872. 1 09 1.4 2488 7

103.

971 S Std Vit C Vit E Vitamin E 3.926 355821.813 1.5 2492 7 103. 971 6 Std Vit C Vit E Vitamin E 3.923 353946. 281 1 4 2482 7 103. 971

Mean 3. S24 3SSOS5. 200

Std. Dev.

0 002

10S3.590

% RSD 0.041 0.297

BaKu Pemfc»anding:

Ascorbic Acid Reg BB 17/02/0055; C = 100 3%. W = 100.016 mg Vitamin E Acetate BB 18/05/522 ; C = 52.0%, W = 49. SS6 mg

User ^4ame: Sad Pudiyastuti (0279)

0S

pie Name nple Type ,oc. Chnl. Descr.

njection Volume Run Time

Pengendalian & Pemastian Mutu PT Phapros Tbk Semarang

H P L C 7

S A M P L E I N F O R M A T I O N

Gr Amaropo Plus 16095003 Unknown

W2489 ChA 286nm 100.00 ul

8.0 Minutes

User Name Date Acquired Acq. IVlethod Set

Date Processed No, Spesifikasi No. Protap

Sad Pudiyastuti_0279 01/Oct/2018 13:56:29 WFT, Beta carotene HPLC 01/Oct/2018 14:04:35 WfT, Inti ( 1 0 - 0 9 5 K l - 0 2 )

TS (10 - 095 K - 02) Inti (11 - 0 9 5 K l - 0 2 ) TS (11 - 0 9 5 K - 0 2 )

0.50-

0.40-1

0.30-

0.20-!

0.1 OH

0.00-

0.00 1.00

/ _-51-

/ /

CM

/

1 i

§

1 <

c s.

j o _CO

j ^\L O

CO j O

1

' - - . - ^ I . i ' - - . - ^ I .

j ' - - . - ^ I . v _ CO y

2.00 3.00 4.00

Minutes

5.00 6.00 7.00 8.00

System Suitability Summary Results Name: Beta Caroten

•

Sample Name Name RT Area USP

Tailing

USP Plate Count

USP Resolution

Sample Weight

Amount (%) 1 Gr Amaropo Rus 16095003 Beta Caroten 5.264 938685.324 1.1 1203 2 1.00031 164.369 2 Gr Amaropo Rus 16095003 Beta Caroten 5 263 942126.253 1.1 1201 2 1.00031 164.971

Mean 164.670

System Suitability Summary Results

Sample Name Name RT Area USP I U S P Tailing Plate Count

Sample Weight

Amount (%) 1 Gr Amaropo Rus 16095003 Lycopen 4.095 1900908.248 0.8 443 1.00031 162.636 2 Gr Amaropo Rus 16095003 Lycopen 4.094 1902747.612 0.8 436 1.00031 162.794

Mean ; 162.715

User Name: Sad Pudiyastuti_0279

Peingondaliian & F»omastian Mutu F"T Phapros Tkr>k S&

HRLC 7

S T - A N D A R - r i r s J F O R M A - r i O N

Sample fsleime : Std Uyoopen Betacaroten Sample Typ>e ; Standard

F>roc. Cnnl. Descr. : W24B9 CtiA ZSSnm Injection N/olume : 100.00 ul

Run Time 8 O Minutes

User IMame Dette Accjuired Acq. Method Set Date Processed

Sad Pudiyastuti 0279 01/0ct/2018 12:41 I S WIT.

Beta carotene HPLC 02/Oct/201S 6:SS:40 WIT.

o.ooo^

0.08S"

o.oso-

O D7S^

O-OTO- O-OSS^

O 060-:

0.055—

1

O 045-^

0.030-0.02S-^

i

0.020-£

0.02S-^

0.020-£

%

0_01 5~

! !i \

O 01 o£

1 ,| ]

nl \

0.005-

hi \

o.ooo—

o. DO 1 .oo 4..00

Minutes

Syaetom S u i t a b i l i t y S u m m a r y R e s u l t s

1 Sample Nsime Area

Xailing

USP RIat© Couint

USR Resolut ion

Amount

1 3td i-ycopen Bertacaroten B«ta Caroten 588020.714. 1.1 121 O 2 1 03.220

2 Std Lycopen Betacaroten 3et3 Caroten 5.26-* 567081 .3Q2 1.1 I 2 0 E 2 1 03.220 3 Std Lycopen Qetacaroten B«ta Garotan 5.25S SOi 209.437 1.1 1204 2 103.220 4- Std t-yoopert 6etacaroten Beta Caroten 5.270 587474.205 1.1 121S 2 103.220 5 Std L.ycopen Betacarot»n El«ta Carotin 5.267 592331 .S4.0 1.1 1 1 ss 2 103.220 Std L-ycopen Betaoaroten 5.272 5S7B20.1 74 1.1 1 2 1 O 2 103.220

Mean S.266 589289.627

Std Dev. 0.006 2012.1 31

\3 0.341

S y s c e m S u i t a b i l i t y S u m m a r y R e s u l t s N a m « : l-ycc>r>en

Sample Nsm«a Name RT • Area (

USR USR

RIsito Count

Amount

1 Std Uycopen Betacaroton Lycopen 4,101 1226797.985 1 .O 981 105.231 2 Std Lycopen 3atacaroter> Ly eopen 4.099 12210S3.770 1 .O 978 10&.231 3 Std Lycopen Betaoaroten i Lycopen 4.099 1220020 7SO 1.0 984 105-231 4 Std Lycopen Betacaroten Lycopen 4.1 OS 1262004.712 0.9 962 1 OS.231 5 Std Lycopen Betacaroten Lycopen 4.1 03 1225396.1 71 1 O 975 105.231 S Std Lycopen l3etacaroten Lycopen 4.103 1221632.OSS 1 .O 983 1 OS 231

M«an 4.102 1229567.571

Std. Dev. O 003 16124.001 .. .J

% FtSD

1

^{0.061 1 .31 1}

Lycopene 10% BB 18/02/0703; C = 1 0.5%; W = SO. 1 1 O mg Betacarotene 20% BB 17/02/0Qa0: C = 20.6%: W = 30 064 mg

10 •

/Vnalis : Sad Pudiy^istuti_0279

0S

pie Name ,nple Type roc. Clinl. Descr /njection Volume Run Time

Pengendalian & Pemastian Mutu PT Phapros Tbk Semarang

HPLC 7

S A M P L E I N F O R M A T I O N

Gr Amaropo Plus 16095003 Unknown

W2489 CITA 286nm 100.00 ul

8.0 IVIinutes

User Name Date Acquired Acq. Metliod Set Date Processed No. Spesifikasi No. Protap

Sad Pudiyastuti_0279 01/Oct/2018 19.25:20 WFT, Beta carotene HPLC 02/Oct/2018 7:04:49 wrr Inti ( 1 0 - 0 9 5 K l - 0 2 )

TS (10 - 095 K - 0 2 ) : Inti (11 - 0 9 5 K l - 0 2 ) TS (11 - 0 9 5 K - 0 2 ) 0.80

0.70-

0.60-

0.50

3 0.40

0.30-

0.20

0.10-

0.00-

0.00

i n

c 8

1.00 2.00 3.00 4.00

Minutes

cn CO CO i n

c o O

CD

CD ,

"S ->t-N

5.00 6.00 7.00 8.00

System Suitability Summary Results Name: Beta Caroten

r "

Sample Name Name R T Area USP

Tailing

USP Plate Count

USP Resolution

Sample Weigiit

Amount (%) 1 Gr Amaropo Plus 16095003 Betacaroten 5.339

j

866943.481 1.5 2345 1.00046 147.808

2 Gr Amaropo Plus 16095003 Beta Caroten i 5.331 822579.624 1.5 2405 2 1.00046 140.244

Mean i ^144.026

System Suitability Summary Results

Sample Name Name

1

RT Area USP Tailing

USP Plate Count

Sample Weigiit

Amount (%) 1 Gr Amaropo Rus 16095003 Lycopen 4.165 2083729.272 0.9 2046 1.00046 176.872 2 Gr Amaropo Rus 16095003 Lycopen 4.171 1931671.004 1.0 1250 1.00046 163.965 Mean

...

170.418

01.10.2818 i5tS2:50 ID 16095903—656

&50.3 mq

User Name: Carvina_2304M

Sample Name Sample Type Proc Chnl. Descr.

Injection Volume Run Time

Rengendalian & Remastian Mutu PT Rhapros Ttok Se HPLC T

S T / \ r M D / \ R T -

Std Lycopen Betacaroten Standard

W24SQ ChA 286nm 100.00 ul

SO M i n y i t ^

i r s J R O R M A T - I O N

User Name Oate AcciLJired Aoq. rviethod Set Osite R racessed

SacJ RLJCliysistuti_027'©

01/0ct/2018 12:-41: 1Q \ A / r r , Beta oairotene HRLC 02/Oct/201S 7.04:29 WIX

0 . 0 © 5 -

O . O S S - - o . o s o -

O . O T O - O . O Q S - ^ O . O O O - o.oss-q o.oso^

0-040-^

0.030^

o.oss-^

0 . 0 2 0 - 5 0 . 0 1 S T O . O I O - j 0 . 0 0

s -

0 . 0 0 0 -

4 . 0 0

S y s t e m S u i t a b i l i t y S u m m a r y R e » j i l f c »

S a m p l e N a m e j N a m e

1 R X j A r e a

U S R XailirtQ

U S P R l a t e C o u n t

U S R ResolLJt i o n

A m o u n t

1 Std i_ycopert Betecaroten Beta Caroten e o s s s 4 - i as

1

^{-2 1 1 dO 2 1 03-220}

Std L-ycopen Betacaroten Bete Caroten 5.264 604003.Q80

1

^.2

1 1

^{92 2 1 03.220}

3 Std Lycopen Betacaroten Beta Caroten &.25S e05312-1 34 1 -2

1 1

^{86 2 1 03-220}

4 Std Lycopen Betacaroten Beta Caroten

5 . 2 r o

604477.0©7

1

^{.2 1207 2} 1 0 3 . 2 2 0 S Std Lycopen Betacaroten Beta Caroten 5.267 604886.608

1

^{.2 1 1 S I}

2

^103.220

© Std Lycopen Betacaroten Beta Caroten S-272 605560,S5S 1 .2 ₁

1

^{94 2} 1 0 3 . 2 2 0 5.266 e o s i 3 a . i 3 0

Std. Dev. 0.00& 431 .eoo

% «SD O.OSS 0-071

S y s t e m S u i t a b i l i t y S u m m a r y R e ;

S a m p l e N a m e N a m e i=lX

—

A r e a U S R 1 U S R i A m o u n t X a i l i n g j R l a t e C o u n t j (%) 1 Std Lycopen Betacaroten Lycopen

4 . 1 0 1

1234855-1 3Q 1 . 0 \ \1

2 Std Lycopen Betacaroten Lycopen 4.099 1236200.956 1 . 0 972

1 0 s . 2 3 1

3 Std Lycopen Betacaroten Lycopen

4.099 1 123S190.39B 1

. 0

^©73

1 05.231

4 Std Lycopen Betacaroten Lycopen 4.1 OS 1256699.386

0

^{9 965} 1 0 S . 2 3 1 5 Std Lycopen Betacaroten Lycopen 4.103 123SaS0.473 1

. 0

^{©71 1 OS.231}

6 Std Lycopen Betacaroten Lycopen 4.103 12361 19.S10

1

. 0

^{97 7 1 OS .231}

Mean 4. 1 D 2 12391 57.692

Std. Dev. 0.003 861 0 . 1 53

F=*SD 1 ⁰ o e i 0.695

j

Lycopene 10% BB 18/02/0703; C = 10. S<K>; W = SO. 110 mg Betacarotene 20% BB 17/02/0980: C = 20.6%; W = 30.064 mg

Analis : Sad l='udiyastuti_0279

3 rms • Pengendalian & Pemastian Mutu PT Phapros Tbk Semarang

HPLC 7

S A M P L E I N F O R M A T I O N

jmple Name Jam pie Type Proc. Chnl. Descr.

Injection Volume Run Time

Gr Amaropo Plus 16095003 Uni<.nown

W2489 CiTA 286nm 100.00 ul

6.0 I\/linutes

User Name Date Acquired Acq. IVlethod Set Date Processed No. Spesifil<asi No. Protap

Wiwied-0489

02/Oct/2018 0:28:01 WIT, Beta carotene HPLC 02/Oct/2018 0:36:30 WIT, Inti ( 1 0 - 0 9 5 K l - 0 2 )

TS (10 - 095 K - 0 2 ) Inti (11 - 0 9 5 K l - 0 2 )

TS (11 - 0 9 5 K - 0 2 ) 1.20-

O.OOH

4.00 Minutes

System Suitability Summary Results Name: Beta Caroten

8.00

Sample Name Name RT Area USP

Tailing

USP Plate Count

USP Resolution

Sample Weight

Amount (%) 1 Gr Amaropo Plus 16095003 Beta Caroten 5.271 866722.085 1.1 1104 2 1.00339 125.929 2 Gr Amaropo Pkjs 16095003 Beta Caroten 5.272 868400.385 1.1 1092 2 1.00339 126.173

Mean _i 126.051

System Suitability Summary Results

Sample Name Name RT Area USP Tailing

U S P 1 Sample 1 Amount Plate Count Weight (%) 1

2

Gr Amaropo Plus 16095003 Lycopen 4.101 1934644.847 0.8 481 1.00339 1 165.940 1

2 Gr Amaropo Rus 16095003 Lycopen 4.099 1932283.597 0.8 484 1.00339 1 165.738

Mean ⁱ _i ! 165.839

User Name: Wiwied-0489

Rongenclalian & Pemastian IVlutu PT Phapros Tfcik: St MF=l_c 7

Sample lype Proc CInnl. Descr.

Injection Volume Run Time

S T A I M D A R T

Std Lycopon Botsiosaroton Stanaara

100.00 L i l

8- O Minutes

I N R O F t M A T I O r s I

User Msirne Oate Acciuired ACQ. Method Set Oate Rrooessed

Wiwied-04SQ

01/0ct/20i8 23:-13:-*3 WIX, Beta carotene HRL.C 02/Oct/201S 0:3e;02 WIX,

o.oso-

/ \

J

I... .

o.bo 4 . 0 0

MHn utes

System Suitability Summary Res

Sample Name Name RX Area USR

Xailing

USR Rlate Count

USR Resolution

Amount

<%) 1 Std Lycopen Betacaroten Beta Caroten ; 5.26S 714527-418 1.1 1 o&a 2 103.735

Std Lycopen Betacaroten Beta Caroten 5.270 71 1004.357 1 .1 110S 2 1 03.735 3 \d L-ycopen Betacaroten Beta Caroten saro 71 1 309 101 1 1 1109 2 103-735 A- Std Lycopen Betacaroten Beta Caroten 5.278

5.237

708S53.e66 1.1 1111 2 1 03.735

S Std Lycopen Betacaroten Beta Caroten 5.278

5.237 71 1862.590 1.1 110s 2 2

103.73S 6 Std Lycopen Betacaroten Beta Caroten S.273 71 1QOS.S72 1.1 1 1 04

2

2 1 03.735

N^an 5-271 71 1558.801

Std. Oev. • .004 1 883.781 ^r

% RSD 0.071 o.aes

System Suitabili Name

ty Summary Results : L-y<=o|3en

Sample Name Name RX Area USR

Xaiiing

USR Rlate Count

Amount

1 Std Lycopen Betacaroten Lycopen 4.1 OS 122S8SO.e9S 1.0 01 7 925

1 OS .449 1 05.449 2 Std Lycopen Betacaroten Lycopen 4-1 01 122S921 -109 1 .0

01 7 925

1 OS .449 1 05.449 3 Std Lycopen Betacaroten 1 Lycopen 4.1 02 1224212.030 1 .0 932 1 05.449 4 Std Lycopen Betacaroten j Lycopen 4-104 1223144.463 1 .0 929 1 05.449 5 i Std Lycopen Betacaroten Lycopen 4.104 1224453-190 1 .0 933 105,449 e Std Lycopen Betacaroten Lycopen 4-100 1224854532 1 .0 923 1 05 449

Mean 4.103 1225244.336

Std. Dev. 0.002 1 996.703

% FISD 0.051 0.163

Uycopene 10% BB 18/02/0703, O = -IO.S%; W = 50.214 mg Betacerotene 20% BB 17/02/0QS0; C = 20.e<!<.; W = 30.214 m£

Analis ; Wiwiecl-04SS

'1 a

Rengendalian & Remastian Mutu F*T Rhapros "Tbk HPLC T

Semarang

S A M R l_ E N F O R M A T I O N

iame Types nnl- Descr yn Volume

Or Amaropo Plus 1 eoe5CX33_2 tywH User Name Unknown Date ACQuired

ChA 2S6nm Acq Method Set 100.00 ul Date Processed

7.5 Minutes No.

No.

Spesifikasi

F*rotap

Sad Pudiyastuti_0279 03/0ct/2018 11:47:59 WIX, Beta carotene MPI_C 03/Oct/201S 13: 33:-44 WIT", Inti (10 - Oes K.I - 02)

TS <10 - 09S K - 02) Inti ( 1 1 - OOS Kl - 02)

- r s

^{(11 -}

o e s

^{K - 02)}

Suitability Summary i 4ame; Beta Caroten S a m p l e N a m © N a m e A r e a O S R X a i i i n g

U S R R l a t e C o u n t

U S R R e s o l u t i o n

S a m p l e W e i g h t

A m o u n t (%) 1 Qr An-taropo Plus 1609S003_1 atas ; Beta Oarotert 4.856 722595.837 1 .4 2057 1 1 -OOOOD 1 09.500 2

1

<3r Amaropo F^us ie095D03„1 atas I Beta Oarotert 4.857 724625.422 1 ,4 2070 1 1 OOOOO 109-807 3 Gr Amaropo Plus 16095003„1 tgh i Beta Oaroten 4.858 7591 55.374 1 .4 21 41 2 1 OOOOO 1 1 5-040

•d Gr Arr»aropo F^us 16095003 1 toh Beta Caroten 4.857 758962.342 1 .4 2122 2 1 -OOOOO 1 1 5.01 1 132.624 S C3r Amaropo F^us iQ09&003 1 bw h Beta Caroten 4.8S6 875323.524 1 .4 2064 1 1 -OOOI s

1 1 5.01 1 132.624 e Gr Amaropo t=1us 1Q09S003„1 t>w h Beta Caroten 4.857 874214.890 1 .4 2076 1 1 .0001 5 1 32.456 T Gr Amaropo Rlus ie095003__2 atas Beta Caroten 4.853 771905.S91 1 .4 2079 1 1 .OOOOO 1 16.972 a Gr Amaropo Flus 16095003_2 atas Beta Caroten 4.857 771 577.098 1 -4 1 2D70 1 1 OOOOO 1 16.922 9 Gr Amaropo Flus 16095003_2 toh Beta Caroten 4.855 830198.672 1,4

j

2102 1 1 .0001 5 1 25.787 1 0 Gr Amaropo Plus ie09S003 2 tgHi ] Beta Caroten 4 855 827730 1 81 1-4 2113 1 1 00015 1 25-413 -I 1 Gr Amaropo F=!us •!e09S003__2 t>w H > Beta Caroten 4.854 8241 70.S90 1 .4 21 10 1 1 .OOOOO

1 .OOOOO

1 24.892 124.947 i 2 Gr Amaropo Plus 1©095003„2 t>w h ! Beta Oaroten 4.855 824533-030 1 .4 21 07 2

1 .OOOOO 1 .OOOOO

1 24.892 124.947 1 3 Gr Amaropo Flus 16095003_3 atas Beta Caroten } 4.856 814232.375 1 .4 21 OS 1 1 OOOOO 123.386 1 4 Gr Arrraropo Plus 16095003_3 atas Beta Caroten 1 4.857 81 3359.835 1 .4 2123 1 1 .OOOOO 123.254 1 5 Gr Amaropo Plus 16095003_3 tQh Beta Caroten [ 4.660 81 7707.660 1 -4 2098 1 1 .00031 123.874 IS Gr Amaropo Rus 1 6095003_3 tah j Beta Caroten [ 4-.861 81 8269.946 1 .4 2111

i

1 1 00031 1 23.960 1 -7 Gr Anr»aropo Plus 16095003__3 t>w h j Beta Oaroten • 4-.857 853382-876 \ .4 21 04

i

2 1 .OOOOO 1 29.319

System Suitat>ility Summary Res

S a m p l e N a m e N a m e R X A r e a U S R

1

^{U S R}

X a i i i n g i R l a t e C o u n t

U S R R e s o l u t i o n

S a m p l e W e i g h t

A m o u n t

1 8 Gr Amaropo Plus 16095003„3 law h Beta Oaroten 4.857 849160-721 1-4

i

2125 2 1 OOOOO 128 679

l\/1ean ! ^122.325

System Suitability Summary Results i S a m p l e N a m e N a m e R X A r e a U S R

X a i i i n g

U S R R l a t e C o u n t

S a m p l e W e i g h t

A m o u n t

<%) 1 1 Or Amaropo F1u» 160eS003_1 atas L.y copen 3.646 1301305.T36 0.6 846 1 .OOOOO 1 10.433 2 1 Gr Amaropo Plus 16095003 1 atas Lycopen 3.346 1 273888.973 o.a 92 O 1 .OOOOO 1 08.1 06 3 Gr Amaropo Flus 16095003_1 tgti Lycopen 3.853 1217240.980 1 o 97 1 .OOOOO 103.299 4 Gr Amaropo Plus 16095003_1 tgh Lycopen 3.852 1207797.232 1 o 92 1 -OOOOO 102-497 5 Gr Amaropo Plus 16095003_1 bw h Lycopen 3.844 12521 89.854 o.a 998 1 .0001 5 1 06.249 6 Gr Amaropo Ptus 1609S003_1 bw Pi Lycopen 3-844 1232346.466 OS 975 1 .0001 5 104.565

7

Gr Amaropo Plus 16095003_2 atas Lycopen 3.841 1412451.628 0.8 1 270 1 .OOOOO 1 19.665 a Or Amaropo Plus 1609S003_2 atas Lycopen 3.S4S 1 393881 .324 O.S 1 236 1 .OOOOO 1 18.289 9 Gr Amaropo Plus 1609S003„2 tah Lycopen 3.843 1401 1 1 4.396 0.8 1 296 1 .0001 5 1 18.885 10 Gr Amaropo Plus 16095003_2 tgh Lycopen 3-843 1377724.699 OS 1 324 1 .0001 5 1 16.900 1 1 Gr Amaropo Plus 16095003_2 bw h Lycopen 3 844 1248792 246 OS 106S 1 -OOOOO 1 05-976 12 Gr Arriaropo Plus 16095003 2 bw h Lycopen 3.846 1231923.798 OS 1 121 1 .OOOOO 1 04.545 1 3 Gr Amaropo Ptus ie095003_3 atas Lycopen 3-846 1242844.632 O.S 1 1 30 1 .OOOOO 1 OS .472 1 4 Gr Amaropo Plus 1609S003_3 atas Lycopen 3.847 1230999.175 O.a 1131 1 .OOOOO 1 04.466 1 5 Gr Amaropo Plus 16095003__3 tgH Lycopen 3.647 126131 1 .61 1 0.8 1 221 1 .00031 1 08.702 1 6 Gr Amaropo Rlus 16095003_3 taH Lycopen 3.848 1269852.475 o.a 1 167 1 .00031 i 1 07.730 1 7 Or Amaropo Ptus 16095003_3 bw h Lycopen 3-S57 1 1 33848.598 1 .O 68 1 .OOOOO ! 96.222 1 S Gr Amaropo Plus 160Q5003_3 bw b Lycopen 3 8SS 1 1 3821 2-398 1 O 332 1 .OOOOO 1 96-592 IV/lean

1 107.711 User Name: Sad Pudiyastuti (027S)

Rengendsilian & Remastian Mutu RT Rhapros Tbk HRLC 7

S T / V M D A R T I I M F O R M A T I O N

Sample Name : StcJ Lycopen Betacaroten Sample "Type : Standard

Rroc. Chnl Descr. : W2:-409 ChA aS6nm Injection Volume : lOOODul

Run Xime : 7,5 Minutes

User Name Date Accoutred Acq- Method Set Date Rrecessed

Sad Rudiyastuti_0279 03/0ct/201 e 1 O: -t S: 5© WIT.

Beta carotene MRL.C 03/0ot/20-l S -I 3: 33: 1 O WIT,

0.085-

0.080-

O 07S

O.OTO

0.065-

0.060-]

0-055 ;

0.050--

0.045-

O 03S-J

0.030-^

0.02S-

0.020-

0.01 5

O.Oi O-

0.005

O.OOO

3.00 4.00 Minutes

System Suitability Summary Results

Sample Name Name RX Area OSR

Tailing

USR Rlate Courit

USR Resolution

Amount

1 s t d Lycopen Oetacaroten Beta Oaroten 5.232 682538.088 1 .3 2015 3 102.979 2 Std Lycopen Betacaroten Beta Oaroten 5.237 681682.827 1 .3 20SS 3 1D2.979 3 Std Lycopen Betacaroten Beta Oaroten 5.23-* i aS0005.0t4 1 .3 2061 3 1 02.979

-*

Std Lycopen Betacaroten Beta Caroten 5.237 678797 .©Sa 1 -3 2051 3 102.979 5 Std Lycopen Betacaroten Beta Caroten 5.233 6774.4.7.106^ 1 .3 2048 3 1 02.97©

e Std Lycopen Betacaroten Beta Oaroten S.231 67625 3 Q34 1.3 ! 2045 3 1 02.979

Mean S.234 679564.259

1

Std. Dev. 0.003 2473.21 8

% RSD 0.052 0.364

i

System Suitability Summary Results

Sample Name \e RT Area USR

Xaiiing

USR i Amount Rlate Count | <%) 1 Std Lycopen Betacaroten Lycopen 4-090 1266520-980 1.1 1 747 10G.227 2 Std Lycopen Betacaroten Lycopen 4.097 1257380.989 1.1 1 793 105.227 3 Std Lycopen Betacaroten Lycopen 4.094 1249779.633 1.1 1S5S 1 05.22 7 4 Std Lycopen Betacaroten Lycopen 4.094 1242902.675 1 .1 17S2 1 OS .22 7 5 Std Lycopen Betacaroten Lycopen 4.094 1223873.666 1.1 1 74© 1 OS 227 6 Std Lycopen Betacaroten Lycopen 4.093 1 1 99314.407 I 1 . 1 1 799 1 OS .227

Mean 4.004 1239962.058 1

Std. Dev . 0-002 24596.323 {

% RSD I O.OS4 1 -984

j \

Uycopeoe IQOX. BB 1S/02/Or03; C = -10.S%; W = SO. 10S mg Betaceroteno 20<M. BB 17/02/0960: C = 20.e%; W = 29.99-4 mg

Sad Rudiyastuti_027'9